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Discussion

Efficacy of Vyaghriharitaki Avaleha on Chronic Bronchitis Page 65

Discussion on APC, ACT and the relevance of the Clinical trial project

The system of Ayurveda has undergone many vicissitudes in the course of

its long and chequered history. However, it still remains the mainstay of medical

relief to the majority of the people in this country. Even in the neighboring countries

the system of Ayurveda is reported to be fairly prevalent. During the medieval period

the system of Unani medicine was introduced and it was only in the sixteenth century

A.D. that the western (allopathic) system came to be introduced in the country.

However, Ayurveda continues to be the largest system of medical relief for the

masses.

Till recently Ayurvedic medicines used to be prepared by the practicing

physician himself for the use of their patients. Physicians were qualified for

identifying the single drugs and trained in the various processes of preparing the

compound formulations. The physician was at liberty to modify the composition of

any preparation according to prevailing conditions and with a view to serve the needs

of any individual patient. In course of time, though the name of the formulation

remained the same, variation in composition became an established practice. This

resulted in the same preparation having different composition as well as different

therapeutic indications. This inevitably resulted in a sort of confusion in the minds of

unwary physicians who find themselves at a loss to choose an appropriate remedy. In

the case of individual drugs, on account of various ecological factors, the same plant

has varying properties depending upon the region, the climatic conditions of its

growth etc. The text is being interpreted in regional languages and conclusions

drawn, as based on the actual clinical experience of the physician in that region. Due

to lapse of long period and the break of continuity over the ages, drugs which were at

one time identified with one term have now been equated with others of the same

name. All these factors have contributed, as in the case of formulations, to a state of

uncertainty about the identity and use of the drugs.

The practice of the individual physician identifying drugs and preparing

medicines himself for the use of his patients has been largely supplanted by the

Pharmaceutical Industry. No longer, except in a few cases, does the physician,

DISCUSSION

Discussion


particularly in the urban area, undertake to prepare their own requirements of drugs;

they prefer to purchase them from the market. Even the patient has become more

sophisticated and prefers purchasing a readymade drug from a manufacturer instead

of obtaining it from his own physician. On account of increasing urbanization, the

tendency is towards more and more dependence on readymade preparations. The

increasing need of the population and the chronic shortage of authentic raw materials

have made it incumbent that some sort of uniformity in the manufacture of Ayurvedic

medicines should be brought about. Evolution of standards for Ayurvedic drugs, in

the modern sense, considering the vast number of such drugs and their formulation, is

a time-and money-consuming task, and will take considerable time for its

achievement.

In view of the present trend of commercialization in the preparation and

marketing of Ayurvedic medicines and to ensure the interests of the profession and

public, the Government of India considered it expedient to utilize the existing law

which controls the standards of allopathic drugs, namely the Drugs and Cosmetics

Act, 1940, to also control, in a limited measure, the Ayurvedic, Siddha and Unani

drugs by amending the Act. The Act was accordingly amended in 1964, to ensure

only a limited control over the production and sale of these medicines.

The Committee in compiling the Formulary has chosen 444 preparations

pertaining to various categories on the basis of their wide use in the country. While

the use of other preparations of a like nature or character is not ruled out, the

Committee hopes that adherence to the Formula and methods of manufacture adopted

in this Formulary will be the first step to secure uniformity. The Formulary includes

in it a cross section of the various categories of authentic preparations described in

Ayurvedic Texts1.

This project named Ayurvedic Clinical Trials (ACT) has been undertaken by the

Ayurvedic Pharmacopoeia Committee (APC) to clinically evaluate the efficacy and

safety of the drugs enlisted in the formulary that is prepared using the standard raw

materials and standard methods of preparation. On such drug of the formulary,

Vyaghriharitaki Leha, is being taken to evaluate its clinical efficacy in Chronic

bronchitis.

Discussion


Discussion on Disease Review

The respiratory system is, involuntarily, the most vulnerable system in the

body. It is always at a risk of being exposed to all kinds of air-borne infections and

irritants like pollution, dust, chemical fumes etc with the process of respiration.

Though, it has its own defense mechanism to look after these exposures, but just like

any other system or organ in the body, it has its own threshold and limitations. The

Nature, which has been created to facilitate easy and healthy survival of all living

organisms, is being, unfortunately, destroyed by the human species. The air, the

water, the Mother Earth, everything, which is essential for existence is now being

ignored to such an extent that this ignorance costs health of living organisms.

Exposure of the respiratory system to various irritants results in the

inflammation of the bronchial mucosa, which is known as bronchitis. Acute bronchitis

is caused by infections in which the inflamed mucosa returns back to its normal

condition after the infection subsides. But, when the bronchial mucosa is exposed to

irritants for a long time, leading to chronic inflammation of the bronchial mucosa, it is

called Chronic bronchitis.

Chronic bronchitis is defined by the American thoracic society in clinical

terms as chronic cough and expectoration when other specific causes of cough can be

excluded. Chronic means that the cough and expectoration have persisted for at least

three months and this pattern has been repeated for at least two consecutive years.

Chronic bronchitis is classified under the broader heading chronic obstructive

pulmonary diseases (COPD) because of the core pathological process of the

obstruction to the airflow which is not fully reversible. Chronic bronchitis can be

included in COPD only in the stage when chronic airflow obstruction occurs. In other

words, it should be kept in mind that patients of chronic bronchitis, which will, in

later stage results in chronic airflow obstruction, can be without any airflow

obstruction for years.

The predominant symptom of productive cough and being a part of chronic

obstructive pulmonary disease, it can be correlated with various diseased conditions

like Kasa, Shwasa and Rajayakshma, mainly with Kasa.

There are two hypotheses- Dutch hypothesis and British hypothesis, which

also support that the Chronic bronchitis may have overlapping pathophysiologies of

Discussion


Kasa, Shwasa and Rajayakshma. These hypotheses endorse the classification of the

disease Kasa as Kshayaja and Kshataja subtypes, along with its doshika subtypes.

The Kasa, Shwasa and Rajayakshma are the three clinical presentation of the

Pranavaha srotasa, which may be sequential, interdependent or unified.

Etiology:

Respiratory infections, smoking, airway hyper-responsiveness, occupational

exposures to dust, coal mining, cotton textiles etc, ambient air pollution are other risk

factors. Severe α1- antitrypsin (α1-AT) deficiency is a proven genetic risk factor for

COPD.

Smoking is the best example of pragnyaparadha2. It is voluntarily exposure of

the irritant to the respiratory mucosa, in addition to the involuntary exposure due to

pollution etc. It will not be out of place to quote a joke regarding the definition of

cigarette- “a cigarette is a piece of paper rolled around tobacco; on one end of which

is fire and on the other end is a fool”. Pollution has become an inevitable social crime

and its ill-effects on the health are the social punishment to the society. Same is with

chemical fumes also. It is the demand of the artificial things in the society which has

increased the industries which pollutes the environment.

Etiology from Ayurvedic point of view:

Ayurveda, due to its all specific principles of disease production has accepted

many factors which are not described in modern texts. But, slowly such factors role is

being accepted in the light of epigenetics. When the disease Kasa, which can be

correlated with Chronic bronchitis, is critically analyzed, few additional important

information regarding the etiological factors are found.

Vishamashana and Vegadharana in the manifestation of diseases are,

unfortunately, the most ignored etiological factors. These have been so

underestimated that they have not even been accredited in modern medical science as

an etiological factor of Chronic bronchitis. But in Ayurvedic literature, these are given

so much importance that even the subtypes of the disease Kasa is named after these

causes other than the doshika subtypes. These factors need understanding and due

respect, especially in cases of respiratory diseases including Rajayakshma.

The classification of Kasa as Kshayaja and Kshataja in addition to the doshika

varieties3 indicates that the symptom of Kasa can be manifested by the

pathophysiology of these three diseases viz. Kasa, Rajayakshma and Kshataksheena.

Discussion


So, the nidanas of three diseases can be, altogether, taken as the nidana of Kasa.

Same is correct for the samprapti also.

Samavayi and Asamavayi nidanas

Samprapti of any disease is mostly explained with the beginning of the

vitiation of doshas with six stages of disease production (shatkriyakala)4. But, at the

same time, it is also true that, in many conditions, the deviation from the normal

physiology, in itself, leads to a different samprapti in the manifestation of a disease –

like in case of Rajayakshma and vega-vidharanajanya vyadhi. Though it is true that

the vitiation of doshas (samavayi karanas of disease) leads to the deviation in normal

physiology (asamavayi karanas of disease) and vice-a-versa, but these two are given

importance (as nidanas) over each other on the basis of their ability to begin and

influence the course of a particular samprapti. This is the explanation for why the

classification of Rajayakshma is not doshik (doshas are samavayi karanas), but by the

name of the nidanas such as Sahasaja, Sandharanaja, Vishamashanaja and Kshayaja5

(these are asamavayi karanas). These names are on behalf of the complete different

routes of samprapti giving the same outcome. Of course, in case of Rajayakshma,

these nidanas (asamavayi karanas) are so powerful and influencing that they lead to

comparatively more ‘kshaya’ of body mass. On the other hand, when these nidanas

(asamavayi karanas) are not so powerful and influencing, they are capable of

producing sign and symptoms other than acknowledgeable ‘kshaya’; and when the

vyadhi-adhisthan is especially pranavaha srotasa (in case of Rajayakshama, the

adhisthana is more generalized), then the samprapti leads to Kasa. Then these are

included under the non-doshika subtypes of Kasa – Kshayaja and Kshataja.

Therefore, from the ayurvedic point of view, Vishamashana, Vegadharana, Kshaya

and Sahasa are the other etiological factors which need to be taken into account along

with the conventional etiological factors mentioned in the modern medical texts.

All the etiological factors can be classified under the two major categories in

Ayurveda which lead to vitiation of Doshas (dosha gunai sama) and which cause

vitiation of Dhatus (dhatubhi vigunah:) as ‘srotas dusti hetu’. The complete

pathophysiology of the disease can be summarized in the four srotas dusti types-

‘atipravritti’, ‘sanga’, ‘siragranthi’ and ‘vimargagamana’. The signs and symptoms

can be correlated with the signs and symptoms of Pranavaha sroto-dusti.

Discussion


It is worth recalling that all the systems in the body are directly or indirectly

interdependent. The respiratory and the cardiovascular systems are so interdependent

that it will be more an act of omission if these systems are called separate. At the

same time, both systems are inseparable with the digestive system. Ahara Rasa and

the Rasa dhatu are the interconnection among them. Ura: is kaphasthana. Its

functional normalcy depends on the quality of Kapha ‘dhatu’ (dharanat dhatava:).

Being produced as the mala of Rasa, the quality of Kapha dhatu depends upon the

quality of Rasa dhatu which instead, depends upon the quality of ahara Rasa

produced. The quality of ahara Rasa depends on the status of the digestive system.

And, the status of the digestive system depends on various factors- prakriti, agni,

ahara parinamkara bhava, ahara vidhi visheshayatanani, status of purishavaha

srotas, compliance of dharaneeya and adharaneeya vega etc. The understanding of

permutations and combinations of interconnections and interrelations among the

srotasas are very useful in ‘avasthika chikitsa’ of any disease.

The modern medical science has mainly included the changes in the

respiratory system in the pathophysiology. But, Ayurveda has a more ‘inclusive’

concept including the physiological changes in the annavaha strotasa and the

avarana of Vata as well, in the pathophysiology.

It may be worth noted that the etiological factors like vishamashana, veg-

dharana, kshaya etc are not emphasized in the contemporary medical science.

But, as discussed above, these may also play a vital role in the manifestation of

the disease. If these factors are not considered as etiological factors then, of

course, prevention of these can not be advised. Though, in the definition of

Chronic bronchitis itself, by saying that “when other specific causes of cough can

be excluded”, indirectly it has been accepted that there may exist other etiological

factors which are unknown (or not acknowledged) till date. It can be suggested

that the asamavayi karanas like vishamashana, veg-dharana, kshaya etc can fill

this lacuna to some extent.

Few clinical research works have correlated the chronic bronchitis with

Kaphaja Kasa67

. This may be due to productive cough being the main symptom of

Chronic bronchitis. In this regard, it will be worth to discuss this point in the

perspective of Ayurveda.

Discussion


Chronic bronchitis is not Kaphaja Kasa-

Though productive cough is the main symptom of Chronic bronchitis, it can

not be exclusively correlated with Kaphaja Kasa. As pranavaha srotasa (ura:

pradesha) is a Kaphsthana, any disturbance in it, is generally represented by

production of sputum. Secondly, the nidanas like smoking, pollution, chemical and

fumes are apparently not the cause of increase of Kapha. The production of sputum is

the usual reaction of the bronchial mucus membrane against the irritation caused by

the above etiological factors. So, it can be said that the Kapha that seems to be

vitiated is not the poshaka Kapha, but is the poshya Kapha. So, the production of

sputum is not ‘Swatantra’, instead it is ‘Paratantra’8. It is not ‘Anubandya’; instead it

is ‘Anubandha’9. But this anubandha is of poshya Kapha and not the poshaka Kapha.

(Of course, in case of Kaphaja variety, there is swatantra vriddhi of poshaka kapha).

There are two ways of deciding the predominance of doshas in a diseased condition-

by observing the lakshanas10

and by knowing the hetus11

. If the vyadhi is Swatantra

then the lakshanas can be correlated with the hetu sevana, but if the disease is

Paratantra, the lakshanas can not be correlated with the hetu sevana.

When we carefully observe the hetus of chronic bronchitis like smoking,

pollution, dust, chemical fumes etc, these hetus are not having the gunas of Kapha. So

they cannot increase the Kapha dosha. These hetus are of ushna, tikshna, ruksha guna

and are irritants to the bronchial mucus membrane. Hence, chronic bronchitis cannot

be correlated with Kaphaja Kasa on the basis of its chief sign and symptom of

‘productive cough’. It can also be confirmed with the presence or absence of

swasthana vriddhi lakshana of Kapha like Gaurava, Alasya, Tandra etc12

.

Swanidanen prakupita Vata may Avritta sthanika Kapha which is represented in the

form of excessive expectoration due to irritation of mucus membrane.

Nija variety can be correlated with Kaphaja Kasa or any other Kasa depending upon

the signs and symptoms.

Pathophysilogy (Samprapti)

From the point of view of Ayurveda, the pathophysiology of Chronic

bronchitis does not have a single specific route of manifestation. Instead, it has

multiple routes for manifestation. This is important to understand because the

treatment modality needs a modification according to the samprapti13

. There are

Discussion


external etiological factors like smoking, pollution, dust etc which leads to the

manifestation of the disease Chronic bronchitis. The other internal etiological factors

like dosha prakopaka hetus, Vishamashana, Vegadharana etc leads to the

manifestation of the disease which can be called as ‘nija Chronic bronchitis’.

Agantuja hetus play a direct role in chronic inflammation of the bronchial mucosa due

to direct irritation. The nija hetus plays an indirect role in chronic inflammation of the

bronchial mucosa through vitiation of Agni, Doshas, Dhatus and srotasas, making the

system more susceptible for inflammation. It hampers the inherited threshold of the

system for the irritation by the external irritants.

Pathophysiological changes in the airways are reversible to much extent. It has

been shown that middle-aged smokers who were able to successfully stop smoking

experienced a significant improvement in the rate of decline in pulmonary function,

returning to annual changes similar to that of nonsmoking patients. Thus, all patients

with COPD should be strongly urged to quit and educated about the benefits of

quitting14

. This explains that the body has an inherited capacity of ‘healing’. This

capacity is affected by the hetus- nija and agantuja. If the hetus could be avoided, it

will be a great help towards the treatment of the disease15

.

Additional ayurvedic aspect

All the above description of pathophysiology may be summarized under the

heading of srotodusti hetu16

and srotodusti lakshanas17

. Chronic exposure to the

irritants resulting in the inflammation of the bronchial mucosa can be explained by the

effect of hetu – ‘dhatubhi viguna’. The various changes resulting in the narrowing of

the airways along with the hyperplasia of the bronchial mucous glands, hypertrophy

of the smooth muscle within the bronchial walls, and an increase in the number of the

goblet cells are ‘siranam granthi’ srotasa dusti. The production of increased amount

of mucous is atipravritti and plugging of the smaller airways is sanga.

Respiratory system is Vata-Kaphasthana. Prakrut Kapha is essential to

present in sufficient quantity so that the whole system can withstand the effect of the

process of respiration. But, because the mucus cells are already inflamed or affected,

they could not produce the mucus of desired quality. Now, the important point is, if

the mucus produced is not of desired quality, then the quantity of mucus produced is

further increased, so that the required amount of the desired ‘guna’ can be maintained

Discussion


in the system. For e.g. – the ‘snigdha’ guna is most essential guna required in the

respiratory system to counteract or balance the ‘ruksha’ guna produced by the process

of respiration. If the snigdhata in the mucus produced is less than the normal or

desired level (due to the production of poor quality of mucus due to the damaged

membrane, then the body will try to produce more quantity of mucus so that the

‘snigdhata’ desired in the system could be maintained). This is the samprapti behind

the productive cough (atipravritti) in the response to the constant irritation of the

bronchial tree with the etiopathological factors like smoking, pollution, chemical

fumes, dust etc.

One more important pathophysiology resulting in similar process of

production of hypo-quality is ‘improper digestion’ (at jatharagni level, dhatvagni

level or bhutagni level). Vitiation in any of the ‘ahara parinamkara bhava’, ‘ahara

vidhi visheshayatana’, ‘viruddha ahara’ etc can lead to the production of hypo-

quality of Kapha, eventually leading to excessive production of mucus. It is obvious

that, if the above two pathophysiologies goes hand to hand, this will add up to the

situation.

Mucus, surfactant etc saumya and aapya bhava can also be taken as different

forms of Kapha. When the kapha is vitiated, the surfactants etc also get vitiated. This

affects the process of ventilation, and this is responsible for the various symptoms

related to hypoventilation.

The respiratory system and the cardiovascular systems are so much

interdependent with each other to execute their functions. When the heart function is

affected, it affects the lung functions and vice versa.

If the ahara rasa is not properly metabolized, then the pichchhil and manda

guna of ama makes the flow of Rasarakta sluggish which, in turn, adds ups to the

hypoventilation, manifesting the various associated symptoms.

The end result of various obstructive pulmonary diseases is hypoventilation

(may it be chronic bronchitis or may it be emphysema). Therefore, it can be easily

understood that it affects all the factors which are responsible for proper ventilation.

The ‘external respiration’ and the ‘internal respiration’ both are important for the

proper ventilation of the tissues. The COPD affects the ‘external respiration’ while the

other factors like ‘ama’ affects the ‘internal respiration’. (This can be understood by

comparing it with the mechanism of type I and type II diabetes. In type I, production

Discussion


of Insulin is affected and in type II, peripheral utilization of Insulin is hampered. Not

only this, the quality of Insulin is also affected.)

Having understood this, it is now clear that, even though, in contemporary

medical science, Chronic bronchitis is considered as a disease of respiratory system

and said to be a progressive disease, it can be better managed with ayurvedic

principles if the addition etiological factors like Vishamashana, Vegavidharana etc

are taken into account from the ayurvedic point of view.

Management of Chronic bronchitis

First of all, it is worth mentioning that whatever the difference in

understanding of philosophy in both the sciences, ultimately treating the same patient,

with the same complaints. To diagnose from the point of view of one system and to

treat with the point of view of another system needs an understanding and acceptance

of the point of views of both the systems. In true sense, medicines don’t belong to any

system, but the treatments do18

.

Both systems do agree that every disease have its etiological factors, which

should be understood, found and avoided. Without this it is not possible to cure any

disease.

In this context, with the discussion in the section of etiology, it is noted that

there may be few more etiological factors like Vishmashana, Veg-dharana,

Dhatushaya etc apart from what are mentioned in the contemporary medical science.

These factors are in addition to the other factors responsible for the dosha prakopa in

the body. Dosha-prakopaka factors, role of Vishamashana, Veg-dharana,

Dhatukshaya etc in the pathophysiology of productive cough or Chronic bronchitis

could only be understood by the ayurvedic point of view. Of course, research projects

may be taken to find out and understand the role of these factors in the manifestation

of disease to make it understand for the scientific community. It is well elaborated in

ayurvedic literature, and used successfully in the treatment of diseases with the

ayurvedic point of view.

In Ayurveda, whole concept of treatment has been summarized as avoidance

of etiological factors19

. Of course, here, the ‘nidana’ includes the samavayi,

asamavayi and nimitta karanas all together.

Discussion


It is well known that the basic aim of the classification of a disease into

various types is to reach to the planning of treatment of that type. In Allopathy,

different things like antibiotics, mucolytics, expectorants, bronchodilators, anti-

inflammatory, steroids etc are used as per their requirement. In Ayurveda, different

set of procedures (including drugs) are used to tackle the different types of disease.

Also, from ayurvedic point of view, the Pranavaha srotasa is not just

Respiratory system. As in Allopathy, the respiratory system and its functions are

closely associated with the cardiovascular system and vise-a verse; is also influenced

by the digestive system. Therefore, the Kasa is included in the Koshtagata roga. This

makes us understand the manifestation of Kasa due to vishamashana or veg-dharana.

Accordingly, at times, annavaha srotasa is given more importance than Pranavaha

srotasa while considering the treatment. Therefore, categorizing the same disease

through different view points (vidhi samprapti) helps us to choose the treatment

procedures accordingly.

The complete treatment procedure may include Snehana (abhyantara and

bahya), Basti, Vamana, Virechana, Dhoomapana etc apart from the specific

medicines and pathyapathya according to the type of Kasa (Chronic bronchitis).

Considering aims of Ayurveda, maintenance of health and treatment of

diseases, we need to consider several related variables. The management approach is

specific to the stages of Dosha, Dhatu, Mala and Agni, which are the important body

constituents and they operate through various channels (srotasa). Innumerable

combinations of specific state of these components define specific stage of an

individual disease. The diagnosis of the disease is ‘Avastha” (stage) specific. For

example, ‘jvara’ is name of disease stage that involves Rasa Dhatu and disturbance in

Agni. The specific diagnosis ‘pittaja jvara’ conveys involvement of Doshas that adds

more information for management. The Sama and Nirama stage shows the status of

Jatharagni and Dhatvagni. The management is also comprehensive and involves

several modalities including drug, diet, lifestyle, counseling, external therapies and

surgical interventions. The intervention may have specific target for specific stage (for

example, digestion of Ama) hence it is dynamic and with reference to the factors

involved in pathogenesis. The outcome of intervention again has multiple endpoints in

terms of alleviation of symptoms, improving quality of life and regaining healthy state

(Prakritisthapana).

Discussion


This comprehensive view of Ayurveda benefits the patient but poses several

challenges for research. It also calls for development of newer methods and models

for research. Most of the published research of Ayurveda is based on ‘researchable’

methods and models, very few papers discuss core methodological aspects20

.

Chronic Bronchitis as A Lifestyle Disease:

Though, Chronic bronchitis is not clearly mentioned as a life style disorder,

but it is obvious that the poor life style also plays an important role in the

manifestation of the disease and also the outcome of the management of the disease.

Life style includes understanding of Dincharya, Ritucharya, code and conducts

regarding food (ahara), code and conducts regarding sleep (nidra), code and conducts

regarding sex (brahmacharya), Shodhana therapy, Rasayana therapy etc. The factors

of ‘life style’ responsible for the manifestation of the disease may be different as per

the life style of the individual patient. This is to be decided by the physician at the

level of the individual case.

These, life style factors like ajeerna bhojana, vega dharana, akala bhojana

along with dosha-prakopaka ahara-vihara etc are not discussed in contemporary

science as much in detail as in Ayurveda. But the understanding of these factors in

regard with the manifestation of the disease and the outcome of the management

needs a great acknowledgement. This is an advantage of ayurvedic system of

medicine in the management of any disorder by helping the patient to get rid of the

possible lifestyles responsible.

This may the reason why some people with smoking or other etiological

factors get affected with COPD and not all. At the same time, the ‘quantum’ of

etiological factors taken and the ‘quantum’ of signs and symptoms of a disease may

not be proportionate due to the difference in the ‘quantum’ of the ‘life style’ related

factors. Smoking, pollution, dust, chemical fumes and allergic materials are dhatubhi:

viguna – etiological factor of strotodusti (agantuja srotodusti). Similarly, ‘mithya

ahar vihar’ is the etiological factor or the Chronic bronchitis through the route

discussed above, and these factors are generally ‘dosha gunai: sama:’, as they are

responsible for the vitiation of the doshas.

Discussion


Smoking as Mithyayoga of Dhoomapana21

:

Smoking can be correlated with mithyayoga of Dhoomapana described under

Dincharya. It is suppose to be done on regular basis to get rid of mala (kapha) in the

Pranavaha srotasa, produced in small quantities during normal physiological process

of respiration. When mithyayoga and atiyoga of this (in the form of smoking) takes

place, it affects the Pranavaha srotasa by the chronic irritation of the bronchii,

resulting in the pathological changes of Chronic bronchitis, which can lead to COPD.

Nidanarthakara roga22

:

History of respiratory diseases especially pulmonary tuberculosis and

recurrent respiratory tract infections leads to Kha-vaigunya and makes the system

susceptible for inflammation with the minimal etiological factors.

Discussion on Drug Review:

The drug is a part of Universe that has some properties (Svabhava) and

activity. These properties could be modified with various set of procedures

(Samskara). The processing enables augmentation of health promoting properties and

reduces toxicity of medicines. The resultant activity of the drug (or diet) is resultant of

the Svabhava and Samskara. The substances (and non-drug interventions) can be

causative agents or lifesaving modalities. It depends on the context of their

applications and stages of health and disease. These connections are important and

relative.

The relation between all these components are dynamic but governed by set of

rules. For example, drugs for Pitta diseases would require specific set of properties

(e.g. Sheeta. Mrudu, Madhura, Snigdha); however in Saama Avastha certain

properties are contraindicated (e.g. Madhura, Snigdha).

In addition to logical, sequential and linear flow, Ayurveda also adopts multi-

dimensional, one-to-many and many-to-many cause effect relations.23

As described earlier, the trial drug, Vyaghriharitaki has been prepared by

using a standard formula, standard raw materials and standard method of preparation

mentioned in AFI.

Discussion


The two main contains of the trial drug, Kantakari and Haritaki are potent

Kasahara drugs, so they are included in the Kasahara mahakashaya gana24

in

Charaka samhita.

Reported study on S. xanthocarpum further confirms the traditional use of S.

xanthocarpum as a popular complementary medicine to relieve cough and bronchial

asthma.25

Immunostimulatory activity of aqueous extract of S. xanthocarpum fruits on

mice gives strong evidence that the plant is an immunostimulating agent. 26

Haritaki has been mentioned as the best Rasayana drug. T. chebula is having

immunomodulatory activity.27

With the help of various samsakaras, Haritaki has

been mentioned to be effective in various diseases with entirely different

pathophysiology. This is possible due to the Sanskaranuvartana and Rasayana

property. The Rasayana property is due to its doshashamaka, srotoshodhana and

vatanulomana property. This is the prime condition for the Rasayana effect28

. With

these inherited property (prakriti of dravya) when combined and processed with other

drugs (samskara), this Haritaki shows the result accordingly.

The contents of trikatu (Shunthi, Maricha and Pippali) and Chaturjat (Tvak,

Ela, Dalchini and Nagakeshar) are also effective in Kasa. But, when these drugs are

used as prakshepa, the main purpose remains to be deepana, pachana effect and helps

in improving the bioavailability of the drugs with which they are used in. Madhu and

Guda do also possess kaphahara and Kasahara property.

In nutshell, the formulation Vyaghriharitaki is effective in Chronic bronchitis by

acting on the Samavayi karanas (doshas) and Asamavayi karanas (Vishamashana,

Vegdharana, kshaya etc). Its effect on the Asamavayi karanas is the additional benefit

over all the treatment modalities in the modern medical science.

Analytical Study:

Standardization of herbal drugs is a burning topic in herbal drug industry

today. Standardization is difficult because they are usually mixtures of many

constituents and the active principles in most cases are unknown. However it is

possible to generate a physico-chemical fingerprint for the standardization of these

drugs with reference to authentic drugs, for checking variation between preparations

from different companies and for evaluating batch to batch changes during long term

storage.

Discussion


There were almost similar results in Loss on drying at 1100

C, Ash value, and

methanol soluble extractives and the variation was found in Water Soluble

extractives, Acid insoluble ash, Sulphated ash and the pH. Arya Vaidya Sala Lab

results of Water Soluble extractives, Acid insoluble ash and the pH are also not in

accordance with the API-parameters. If the materials used in the preparation of

Vyaghriharitaki Avaleha are of pharmacopoeial standards, then the variations in the

analytical parameters can be mainly due to variation in consistency of the Syrup

(Chasni) and the variation in the jaggery and honey. Difference may also occur due to

the control sample procured by Kotakkal and by pharmacopieal formulation

manufacturing unit has variation in climatic and regional zone in raw material. It also

happens when raw material processing adapted by manufacturing unit is different.

Plain chromatography is non specific and performed in absence of selective reactive

moiety (selected component), but they report fingerprinting on pattern of extracted

component on silica gel as solid phase and specific mobile phase.

Novel techniques like NMR (Nuclear magnetic resonance) spectrometry may

be used to determine the standards for herbs and metabolite detection techniques to

evaluate the quality and also the degradation of a polyherbal formulation. It may be a

promising analytical tool for the detection of a wide range of compounds of a plant.

NMR can identify and quantify metabolites of which no a priori knowledge is

needed29

. NMR based methods have the advantage of acquiring relatively little

sample preparation, being non-destructive and allowing the determination of

molecular structures of individual compounds, even in mixtures. It therefore has a

great potential as a method for quality control of phytopharmaceuticals 30

. NMR has

the advantage of being non-destructive, even in mixture samples31

. The determination

of chemical changes occurring in the various constituents during food storage, using

NMR technology can be a promising tool for evaluating the performance of the

package with respect to its ability of preserving food32

. Other non-invasive techniques

like Fourier Transform Infrared spectroscopy (FTIR), Colour and Visual

Spectroscopy, electronic nose and tongue etc can also be useful.

One more option will be to make standards to check the standard of

formulation like procurement of herbs, various steps in the method of preparation. In

case of Vyaghriharitaki avaleha, the method of preparation is relatively simple. So, if

the ingredients where taken of the pharmacopeia standard and method of preparation

Discussion


is taken care of then that only thing to be verified that the consistency of the final

product. If ingredients are verified for their standards, then there will only be concern

about the method of preparation and their evaluation. Now the things remain is to

detect the degradation of the medicine due to multivariate like type of packaging,

storage condition etc. for this the better option will be metabolite detection and NMR

technique.

From the therapeutic point of view, the variation in Water Soluble extractives,

Acid insoluble ash, Sulphated ash are not of much concern if the ingredient are taken

of pharmacopoeial standards, because these values may differ due to the variation in

the consistency of the syrup (Chasni) or the prepared leha. It may also occur due to

the control sample procured by Kotakkal and by pharmacopieal formulation

manufacturing unit has variation in climatic and regional zone in raw material. It also

happens when raw material processing adapted by manufacturing unit is different.

The variation in pH value can be a matter of concern if the pH is changed due to the

decomposition (some times due to the presence of sugars Avaleha may get fermented,

which is undesired) of the formulation. But, if it is due to the consistency of the syrup

(Chasni) or leha, little variation is acceptable.

Clinical study:

It was an interventional, open label type of study with the purpose of treatment

with the end points of efficacy and safety of the trial drug, Vyaghriharitaki leha (API-

Part-II-Vol.-I:Pg.35-37), for its clinical evaluation in the management of Chronic

bronchitis. No control group was used. The salient features of the study were:

Stringent selection criteria were used to include metabolically stable

uncomplicated cases of Chronic bronchitis between the age group of 16 to 70

years, including subjects of either sex.

The status of the clinical condition and its impact on the respiratory system

was assessed with the help of St George’s Respiratory Questionnaire.

Functional efficiency of the respiratory system (PEFR and FEV1) were

assessed both before and after the intervention by using Electronic Lung

Health Meter (Brand name: PIKO-1; manufactured by nSpire Health, USA)

and functional ability is assessed with the help of the St. George’s Respiratory

Questionnaire. The clinical study is registered in Clinical Trial Registry of

Discussion


India. The summary of the trial protocol can be accessed anywhere from the

CTRI website as well as the International Clinical Trials Registry Platform

(ICTRP). Thus, making it more transparent.

Written informed consent was obtained prior to the registration of each

subject.

Validated, responsible, sensitive and specific criteria of outcome assessment

including subjective and objective parameters were used in the study.

Discussion on Observation:

A total of 66 subjects were enrolled in this trial with the purpose of treatment.

It was open label interventional prospective clinical trial with the end points of

efficacy and safety with proper arrangements for withdrawals. The data obtained was

used for demographic and disease related observations. Among them 61 (92.42%)

completed the treatment schedule and 05 (7.58%) were dropped out. Off the dropped

out patients, one’s job was transferred to other state, one could not come for a long

time due to death of relative out station, one has to go to his native place before

completion of the schedule and two patients discontinued for unknown reasons. So,

the assessment of therapy was based on 61 completed cases.

Age:

Maximum number of 20 (30.30%) patients belonged to the age group of 31-

40 years, followed by 41-50 years age group 13 (19.70%) patients. 12 (18.18%), 11

(16.67%) and 9 (13.64%) patients were from 51-60 years, 61-70 years and 21-30

years of age groups respectively. Only 1 (1.52%) patient was in the age group 16-20

years.

The incidence of Chronic bronchitis is dependent on chronic irritation of the

bronchial tree with the etiological factors. Smoking and pollution are the main

culprits. Smoking is generally started in the adolescent and young age. So the

manifestation of the disease is more found in the middle age group- 30-50years (50%)

and later. Similarly, the exposure to the pollution is comparatively more in the middle

age group and later. This is the most productive age of the life and many were

working in environment which was not healthier.

Chronic bronchitis is more common in middle aged males and females33

.

Discussion


The respiratory muscles, like all skeletal muscles, weaken with age. Lung

tissue loses its elasticity and alveoli are lost as their walls deteriorate. All of these

results in decreased ventilation and lung capacity, but the remaining capacity is

usually sufficient for ordinary activities. The cilia of the respiratory mucosa

deteriorate with age, and the alveolar macrophages are not as efficient, which make

elderly people more prone to pneumonia, a serious pulmonary infection. This is the

reason, why ‘jara Kasa’ is said to be yapya.

Gender:

Higher incidence of the disease was observed in males than females. The ratio

of male subjects 55 (83.33%) to the female subjects 11 (16.67%) observed in this

study was 5:1.

Chronic bronchitis is more common in middle aged males than in females.

Approximately 20% of adult males & 5% of adult women are affected34

.

The high incidence in males than females may be due to relatively high

exposure rates of etiological factors (like smoking, pollution, chemical fumes etc) in

males compared to females.

Religion:

Maximum 55 (83.33%) were following the Hindu religion. This shows the

geographical predominance of the faith. There is no any direct relation of the religion

followed by the subjects with the manifestation of the disease.

Marital Status:

Maximum subjects 50 (75.76%) were married. This was in correlation with

the age-groups selected in the study. There is no direct relation of the marital status

with the manifestation of the disease.

Literacy:

Maximum number 61 (92.42%) were literate. 44 (66.67%) subjects were

educated up to secondary level and higher, which indicates the general level of

education in the society. Status of formal education cannot be directly correlated with

the manifestation of the disease. But, the lack of education regarding the role and

importance of ‘lifestyle’ Dincharya, Ritucharya, Dharaneeya and Adharaneeya

Vegas do play a role in the prevalence of any disease, especially the lifestyle diseases.

Discussion


In today’s world, almost every subject is formally educated, but hardly are ‘learned’

in proper ‘lifestyle’ and its effect on health. Social message to the society in the form

of slogans ‘Smoking is Injurious to Health’ and ‘Smoking causes Cancer’ and various

awareness campaigns taken up by governments indicates the need of awareness in the

society irrespective of literacy level.

Occupation:

A maximum number 23 (34.85%) patients were doing occupation which

involved field work with physical labor followed by 20 (30.30%) patients who were

doing desk work. 9 patients were doing field work and 8 patients were housewives.

Occupation plays a vital role in manifestation of the disease. The jobs which

involves field work with physical labor increases the risk of pollution. Similarly, the

jobs where the subjects has to control his natural urges by force, shift duties, irregular

time of taking food, jobs involving mental stress do effect the normal physiology and

play role in manifestation of disease.

Socio-economic status:

Majority of the patients 58 (87.88%) were belonging to the category of above

poverty line. This also does not have any direct relationship with the prevalence of the

disease but may be representation of the society attending free Govt. Hospital.

Diet:

Maximum 44 (66.67%) patients were vegetarians and 22(33.33%) patients

were of mixed dietary habit.

The diet, vegetarian or mixed, if taken with due consideration of ahara vidhi

visheshayatana, hardly play any role in the manifestation of the disease. It may also be

representation of diet pattern of Hindu society of the area.

Aggravating factors:

21 (31.82%) patients found to be allergic to some material. Maximum 13

(19.70%) patients were found to be allergic to dust.

Aggravating are allergic factors are important to know so that they can be

avoided as much as possible. Allergic factors like dust, perfumes and cold air affect

the respiratory system by their direct contact. The cold food items and cold drinks do

vitiate the doshas and thus play role in the manifestation of the disease.

Dashavidaha parikshya bhava (except vikriti pariksha)

Discussion


Maximum 32 (53.33%) patients belong to Vata-Pittaja prakriti followed by 18

(30%) patients of Pitta-Kaphaja prakriti. Maximum 41 (62.12%) patients were

having Rasasara, maximum 45 (68.18%) were of pravara samhanana, all 66 (100%)

were of madhyama satmya, maximum 50 (75.76%) of madhyama satva, maximum 56

(84.85%) were having madhyama ahara shakti, maximum 33 were of pravara

vyayama shakti followed by 29 (43.94%) were of Madhyama vyayama shakti and

maximum 45 (68.18%) patients were yuvana.

The dashavidha parikshya bhavas (except vikriti pariksha), altogether, gives

an idea about the rogibala and is mainly useful in selecting the drug and its dose in

individual patient. Also, they hint towards the prognosis of the disease and the

treatment. They need to be interpreted by physician on case to case basis.

Chief complaints:

Productive cough, being the cardinal symptom of Chronic bronchitis was

present in 100% patients. Dyspnea in 41 (62.12%) patients, Wheezing in 38 (57.58%)

patients, Chest pain in 23 (34.85%) patients, Sore throat in 37 (56.06%) patients and

Nasal congestion in 47 (71.21%) patients was observed.

Productive cough is the cardinal symptom of Chronic bronchitis. In due course

of time, dyspnoea may develop. Wheezing, chest pain, Sore throat and nasal

congestion are other associated complaints which are observed in the patients.

Chronicity:

Maximum 36 (54.55%) patients were having productive cough for 2-5 years.

Rest of the patients i.e., 30 (45.45%) were having productive cough for more than 5

year’s duration. The data shows that the disease runs a chronic course and due to

unavailable proper diagnostic tool and treatment modality, disease runs a chronic

course.

As the duration of symptoms increases, the changes of COPD become more

prominent. Also, prognosis of disease is inversely proportional to the chronicity.

Chronicity of any disease gives an idea regarding the amount of srotodusti that may

have happened due to the lasting of the pathology for such duration. The chronicity

leads the disease to the kastasadhyata, yapyata or asadhyata35

.

Productive cough usually stars after colds; during winter season show steady

increase in severity and duration with successive years.

Discussion


Smoking habit:

17 (25.76%) patients were having history of chronic smoking for more than 15

years. 1 patient was occasional smoker whereas 48 (72.73%) patients were non-

smokers.

Smoking (Cigarette or bidi) is the main etiological risk factor for COPD.

There are various other factors responsible for developing Chronic bronchitis.

Smoking is the cause which directly irritates the bronchial mucosa. The other cause

like chemical fumes can be taken as a part and partial of this habit. Because, if a

person smokes in an area free of pollution and chemical fumes, still, by smoking only,

he exposes his respiratory system (and the whole body) with a number of harmful

chemicals. Majority of the patients in the study were found non-smokers. This hints at

other risks factors like dust, chemical fumes, dust, ambient air pollution and other

etiological factors of Kshayaja and Kshataja Kasa.

Emotional Stress:

Maximum 58 (87.88%) patients were having average stress level and 8

(12.12%) patients were having moderate stress in their life.

Stress level can not be directly correlated as smoking is generally started as a

fun or in company of smoking friends but people are found who use smoking as

‘stress reliever’.

Chinta is one of the reasons for rasadust36

i. Rasadusti leads to Kaphadusti.

Prakrut Kapha is essential for the proper functioning of Pranavaha srotas. Vikruta

Kapha makes the srotas more susceptible for inflammation.

Bowel and consistency of stools:

27 (40.91%) patients were having irregular bowel habits while 26 (39.39%)

patients found to be passing constipated stools and 4 (6.06%) were passing loose

stools.

Irregular motion habits can be cause and/ or effect of Vegadharana. At the

same time, it can also prompt the physician to rule out any other factors related to

dietary habits as a cause of irregular motions and ultimately resulting in the vitiation

of doshas. Consistency of stools may also indicate the functional status of digestive

system.

Discussion


Another result of vega-dharana is vega-udeerana. A constipated patient will

generally have a habit of applying force to pass motion. Both vega-dharana and vega-

udeerana are cause of many diseases37

(as mentioned in Udavarta).

Agni:

Maximum 25 (37.88%) patients were having Vishamagni and 24 (36.36%)

having Tikshnagni whereas 5 (7.58%) patients were having Mandagni. Samagni was

found in 12 (18.18%) patients.

Agni plays a vital role in maintaining the health. It may become the cause of

vitiation of Doshas and production of Ama if not taken care of.

DISCUSSION ON EFFECT OF THERAPY

Effect on Primary Outcome measures

Effect on Productive cough

Vyaghriharitaki provided very good improvement in the cardinal symptom of

the disease- Productive cough. The improvement was 68.9% which was statistically

highly significant (p<0.001).

Productive cough is the outcome of the pathological changes happening in the

respiratory system due to inflammation with the chronic irritation due to the

etiological factors. Vitiation of Kapha dosha due dosha prakopaka nidanas or due to

Kshayaja samprapti may also result in productive cough. The improvement in the

symptom is due to the accumulative effect of Kasahara, srotoshodhana,

doshshamana, agnivardhana and deepana-pachana property of Vyaghriharitaki. That

is, the improvement in the symptom is due to action of Vyaghriharitaki on both

Samavayi and Asamavayi nidanjanya samprapti.

Effect on Dyspnoea:

The treatment provided 83.30% improvement in dyspnoea which was

statistically highly significant (p<0.001).

Dyspnoea is the result of narrowing of the airways due to inflammation,

hyperplasia of the bronchial mucous gland, hypertrophy of the smooth muscle within

the bronchial walls and plugging of the smaller airways. This is in addition to the

reduced ciliary function that leads to reduction of the airway clearance. The

improvement in dyspnoea is the accumulative effect of doshashamana,

srotoshodhana, agnivardhana and digestion promoting property of Vyaghriharitaki.

Discussion


The reduction in the inflammation of the bronchial mucosa and the reduction in hyper

secretion of mucous due to doshashamana and srotoshodhana effect of

Vyaghriharitaki in reduction of the narrowing in the airways. So, there is

improvement in dyspnoea.

Effect on Wheezing

The treatment provided 100% improvement in wheezing. This improvement

was statistically highly significant (p<0.001).

Wheezing is found due to hyper section in the airways. Doshashamana and

srotoshodhana reduces the hyper secretion and so the wheezing.

Effect on Chest pain:

The treatment provided 100% improvement in chest pain. This improvement

was statistically highly significant (p<0.001). As the pathology in the respiratory

system improves, the avarana of Vata subsides. Hence, the gati of Vata becomes

avyahata. The stress on the whole system reduces. This results in positive

improvement in chest pain.

Effect on Sore throat:

The treatment provided 100% improvement in Sore throat. This improvement

was statistically highly significant (p<0.001). As the inflammation in the mucus

membrane of throat subsides, sore throat also subsides. One more region of sore

throat is Sama Kapha. ‘Kantha deshe avathisthate’ is one of the symptom of Sama

Kapha. With the doshashamana and digestion improving property of the drug, the

production of Sama Kapha reduces resulting in the positive improvement in sore

throat.

Effect on Nasal congestion:

The treatment provided 97.62% improvement in nasal congestion. This

improvement was statistically highly significant (p<0.001). As the inflammation in

the mucus membrane of nasal mucosa subsides, nasal congestion also subsides (Fig.

1).

Effect on FEV1 and PEFR:

There was a little increase of 1.09% in mean FEV1 value following the

treatment with Vyaghriharitaki. This improvement was statistically insignificant

(p=0.426).

Discussion


There was slight decrease of 0.45% in the mean PEFR value with the

treatment. This change was also statistically insignificant (p= 0.656).

Significant change in FEV1 and PEFR values are expected in Bronchial

asthma and COPD. Chronic bronchitis can be included in COPD only in the stage

when chronic airflow obstruction occurs. In other words, it should be kept in mind

that patients of chronic bronchitis, which will, in later stage results in chronic airflow

obstruction, can be without any airflow obstruction for years.

Maximum patients included in the study belong to the chronicity of the disease

of 2-5 years. This duration may not be sufficient to lead Chronic bronchitis to chronic

pulmonary obstruction. As there were not much pulmonary obstruction was found in

many patients, not much change in these values was expected.

Effect on Secondary Outcome Measures

Effect on SGRQ:

There was a little change of 2.35% in the Symptom score which was

statistically insignificant (p=0.275). The improvement in Activity score was 68.89%

and in Impact score was 88.98% which were statically highly significant (p<0.001).

The improvement in the Total score was 59.23% which was statistically highly

significant (p<0.001).

The 12-month version of SGRQ was used which is the original validated

version. The patient has to give the answers to the part-1 (which is related with

Symptom score) by recalling his perception for the whole last year, there was no

much difference expected in Symptoms score during the 12 weeks of clinical study.

So, to get the appropriate picture of the effect of therapy the change in the Total Score

was calculated on the basis of changes in the Activity and Impact Scores. The

modified calculation shows that 45 (73.77%) patients got marked positive response

with the treatment, whereas 10 (16.39%) patients got moderate (50-75%) positive

response, whereas 02 (3.28%) patients got mild positive response. The remaining 04

(6.56%) patient did not get any significant change in his condition. This is much

similar to the overall effect of the therapy calculated on the basis of symptomatic

relief to the patient. The improvement in the modified Total score (calculated on the

basis of Activity and Impact Scores) was 82.14% which was statistically highly

significant (p<0.001) [Fig. 2].

Discussion


The improvement in the Activity score and Impact score was due to the

overall effect (local and systemic) of Vyaghriharitaki. The Kasahara, Srotoshodhana,

Doshshamana, Agnivardhana, digestion promoting property of Vyaghriharitaki play

important role in this improvement by their action on both Samavayi and Asamavayi

nidanjanya samprapti.

OVERALL EFFECT OF THERAPY ON THE BASIS OF SYMPTOMATIC

RELIEF

On the basis of relief in the symptoms to the patients, the overall effect of the

drug on Chronic bronchitis was assessed. It provided marked positive improvement in

54 (89.52%) patients whereas 6 (9.84%) patients got moderate positive response.

Only 1 (1.64%) patient did not get any significant change in his condition (Fig. 3).

Effect on Hematological Parameters:

The comparative effect of therapy on hematological investigations was

statically insignificant except on differential counts of neutrophils and lymphocytes

which were statistically significant. This indicates the positive improvement in the

infection or inflammation.

Effect on Biochemical Parameters:

The comparative effect of therapy on bio-chemical parameters was statically

insignificant except on Conjugated bilirubin which was statistically significant. This

signifies the positive effect of the drug on liver function and general metabolism.

PROBABLE MODE OF ACTION OF VYAGHRIHARITAKI

VHA is mentioned to be effective in all types of Kasa including the Kshayaja

and Kshataja. Very few medicines have been mentioned to be effective in all types of

a disease. In literature, different yogas are indicated in various types of Kasa

exclusively, which indicates that the samprapti of various types of Kasa are different

to many extents. (This is true with other diseases also).

But, as VHA is mentioned to be effective in all types of Kasa, then it may be

due to that these types of Kasa (in which it is indicated) must share a common

samprapti. This is especially possible in case of Vega-vidharanajanya and

Vishamashanajanya Kasa. If the medicine can eliminate the ill-effect of the Vega-

Discussion


dharana and Vishamashana, then the symptom produced due to them would be

eliminated.

It may be noted that Vega-vidharana and Vishamashana follow a specific

samprapti which may lead to Kasa of various doshika lakshana according to the

preexisting predominance of doshas (poshya doshas) in the body.

Vegadharana is mentioned to be cause of various diseased conditions38

. These

results from the hindrance of normal physiological functions, especially of those

functions which are excretory in nature like purisha and mootra etc. But, this vega-

dharana has major contribution in the manifestation of Rajayakshma and Kasa

(Kshyaja Kasa) than in any other disease. This contribution is so great that the disease

itself is categorized on behalf of these causes rather than doshika classifications.

Vega-dharana can be active or passive. Active vega-dharana may be due to

aalasya or due to various compulsions in duty or absence of facilities to release the

vega. Taking food which results in constipation is also a kind of vega-dharana.

Disturbed gastrointestinal functions may also result in passive vegadharana.

Similarly, acharya Charaka explains regarding Vishamashana39

; and Vishamashana is

also given due importance and preference over doshika classification in Rajayakshma

and Kasa (Kshyayaja Kasa).

This explanation is to clarify that though doshas are Samavayi karana of

disease, they do not necessarily play a major role in the initiation and course of the

disease. Many a times, other factors like Vega-dharana and Vishamashana play a

major role in the samprapti of the disease. This is why diseases like Rajayakshma and

Kasa are classified according to their basic causes and not only on their doshik

predominences. In other words, this is the Asamavayi karana eg. Veg-dharana,

Vishamashana which play the major role than the Samavayi karana e.g. vitiation of

doshas. If this asamavayi karana is taken care of, the vitiation of doshas also gets

corrected. VHA corrects this Asamavayi karana.

It is well known that out of three karanas- Samavayi, Asamavayi and Nimitta,

the Samavayi and Asamavayi karanas are essential for the continuance of any disease.

Absence of any of these two will result into the destruction of the product (disease, in

this case).

Also, this asamavayi karana also results in aggravating the symptoms.

Haritaki helps in Kasa by checking this asamavayi karana with its strotoshodhana

Discussion


and anulomana property. Kantakari have local effect on Pranavaha strotasa.

Together they work as a naimaitika rasayana in Chronic bronchitis. Trikatu and

Chaturjat, when used as prakshepa mainly act as deepana –pachana and helps in

promoting the bioavailability of the drug. Honey is also known for its Kasahara

effect. With its Vishada guna, it helps in the srotoshodhana in the respiratory system.

Guda helps with its Snigdha and Vrishya guna.

For the sake of simplification and easy understanding, the manifestation of the

disease can be summarized as the end result of three factors- Doshaprakopa,

Agnidusti and Srotosusti (khavaigunya). Agniduati, in itself, can take place as an

effect of Vishamashana, Vegadharana and Dhatukshaya. There is a vicious cycle of

agnidusti and doshaprakopa (either can be cause or effect of each other).

The manifestation of the disease as a result of Vishamashana follows the

samprapti of Grahani. The manifestation of the disease as a result of Vegadharana

follows the samprapti described in Udavarta, and the manifestation of the disease as a

result of Urakshata follows the samprati described in vegavidharanjanya

Rajayakshma.

The doshaprakopa is corrected by the doshashamana property of VHA. The

effect of Vishamashana is corrected by the srotoshodhana and agnivardhana property

of VHA. The effect of Vegavidharana is corrected by anulomana property of VHA.

The srotodusti (khavaigunya) is corrected with the srotoshodhana and vishadikarana

property. With its brihana property, VHA helps in correcting the dhatukshaya.

Prakrita Kapha is essential for proper functioning of the Pranavaha srotasa

(and all other functions in the body that depends on Kapha). When the Agni and

digestion are corrected, samyaka Rasadhatu is produced and this results in the

production of prakrita shleshama (as mala of Rasadhatu). Thus, VHA helps not only

in correcting the three main factors of the disease- Doshaprakopa, Agnidusti and

Khavaigunya, but also helps in maintaining the proper functioning of the system

which results in sustained positive effect on the srotasa (prakritisthapana) (Flow

Chart No. 6.1).

Discussion


Flow Chart No. 6.1 – Mode of Action-A.

Further, Pranavaha srotasa is vata-kapha-sthana. Its function is mainly

affected by vitiation of Kapha and Vata. Therefore, the avastha of any respiratory

disease can be as either vatavritta-kapha or kaphavritta-vata(Prana). If it is

Kaphavritta avastha, then doshashamana property of VHA helps in relieving the

symptoms and if its vatavritta avastha, then vatashamana and vatanulomana property

helps in relieving the symptoms (Flow Chart No. 6.2). Therefore, VHA is a drug

which may be effective in all the respiratory diseases as mentioned in its phalashruti.

Chronic bronchitis

Vega-dharanajanaya

Vishamashanajanya

Khavaigunya Doshaprakopa Agnidusti

Dhatukshayajanya

Anulomana

Srotoshodhana

Srotoshodhana,

Vishadikarana

Doshashamana

Bruhana

Proper Agni

and

Digestion

Proper Kapha

Production

Maintenance of

Pranavaha srotasa

Discussion


Flow Chart No. 6.2– Mode of Action-B.

VHA, as a whole, corrects the effect of asamavayi nidana of the disease.

Theoretically, it is a better drug for Kasa of Kshayaja type. But, at the same time,

Haritaki with its srotoshodhana and tridosh-hara property will be effective in all

types of Kasa (Chronic bronchitis). The only difference is that doshika variety of

Kasa can be better handled in relatively shorter duration with the specific treatment

procedures indicated for individual doshika variations. VHA can be helpful in all

types of Kasa or Chronic bronchitis

Nidana parivarjana is the foremost and essential prior to any other treatment.

Therefore, a physician should find out the causes and types of vishamashana, vega-

dharana, dhatukshaya etc. After nidana-parivarjana, it is the time to reverse the

effect of nidana and promote and maintain the right physiology (prakritisthapana).

The classification of respiratory diseases as Kshayaja, Kshataja,

Vishamashanaja etc indicates that the respiratory system is affected in two different

ways. One is with the beginning of the doshika vitiation (as in doshika varieties of

Kasa) and the other is with the beginning of physiological disturbances (as in

Rajayakshma and Kshayaja and Kshataja varieties of Kasa).

VHA is designed in such a way that it takes care of all the three components of

disease i.e. Agni, Dosha and Dushya(srotasa). VHA, theoretically, can be used in all

variety of Chronic bronchitis.

Kaphavritta Prana

Chronic bronchitis

Vatavritta Kapha

Kaphashamana Vata shamana

And

Vatanulomana

Relief Relief

Discussion


Kantakari has been proved to be effective in Kasa 40

. Review on reported

activities of Solanum xanthocarpum (Kantakari) shows to improve various

parameters of pulmonary function (FVC, FEV1, PEFR & FEF 25-75%) in Asthmatic

subjects with mild-moderate Asthma; seeds of Kantakari act as expectorant in cough

and Asthma; roots are used as expectorant and diuretic and useful in the treatment of

catarrhal fever, coughs, Asthma and chest pain. The main drug for decoction in

Vyaghriharitaki Avaleha is the whole plant of Kantakari.

To understand the role of Haritaki in the management of chronic bronchitis it

will be useful to discuss the description available regarding Haritaki in ayurvedic

texts.

Haritaki is mentioned to be useful in various diseases of completely different

pathophysiology41

. Haritaki is such a wonderful drug that when its effects on the body

are analyzed, it gives surprise that this drug’s effect on the body, till date, is much

beyond the explanations of present pharmacology which could be given on the basis

of its chemical constituents. The same Haritaki used with different drugs/ substances

in different seasons gives the rasayana effect (Rituharitaki)42

. Haritaki can be used in

different forms as agnivardhaka, vatanulomaka, tridoshashamaka, malashodhaka,

sangrahi43

. Haritaki is also vatashamaka, pittashamaka, kaphashamaka and

tridoshashamaka when used in combination with different drugs44

. The only

explanation for these all effects could be given is its Sanskaranuvartana and

Rasayana property. The rasayana property is due to its doshashamaka,

srotoshodhana and vatanulomana property. This is the prime condition for the

rasayana effect45

. With these inherited property (prakriti of dravya) when combined

and processed with other drugs (samskara), this Haritaki shows the result

accordingly46

.

Though the rasapanchaka of drugs have been mentioned in literature, but the

drugs are classified and groups according to their effect in the body. This is what

ultimately needed by the physician, sometimes more than its chemical constituents or

rasapanchaka. Kantakari and Haritaki both are included in the Kasahara gana47

.

The contents of trikatu (Shunthi, Maricha and Pippali) and Chaturjat (Tvak, Ela,

Dalchini and Nagakeshar) are also effective in Kasa. But, when these dravas are used

as prakshepa, the main purpose remains to be deepana, pachana, rochana effect and

Discussion


helps in improving the bioavalability of the formulation they are used in. Madhu and

Guda also possess kaphahara and Kasahara property.

In nutshell, the formulation Vyaghriharitaki is effective in Chronic bronchitis

by acting on the Samavayi karanas (doshas) and Asamavayi karanas (Vishamashana,

Vegdharana, Kshaya etc). Its effect on the Asamavayi karanas is the additional

benefit over all the treatment modalities in the modern medical science.

Discussion on Overall Effect of Therapy:

On the basis of relief in the symptoms to the patients, the overall effect of the

drug on Chronic bronchitis was assessed. It was observed that 54 (89.52%) patients

got marked positive response with the treatment, whereas 6 (9.84%) patients got

moderate (50-75%) positive response. The remaining 1 (1.64%) patient did not get

any significant change in his condition.

The mean Total score in SGRQ prior to treatment was 32.369 and after the

treatment was 13.196, with a difference of 59.23% which is statistically highly

insignificant with p<0.001. The improvement in the modified Total score (calculated

on the basis of Activity and Impact Scores) was 82.14% which was statistically highly

significant (p<0.001).

This overall effect of the therapy shows that Vyaghriharitaki is very effective

in the management of Chronic bronchitis showing better improvements in both

primary and secondary outcome measures.

“The whole clinical research (as a part of multicentric trial) was for the

purpose of data collection which is a need of hour; otherwise, the overall effect of

the drug and its efficacy and safety has already quoted in literature. Efficacy is

mentioned in the phalashruti that this drug is effective in all types of Kasa,

Rajayakshma and Urakshata. Safety is quoted in its name, giving it a prefix of

RASAYANA. The word Rasayana not only indicates the safety of the drug, but

also indicates at the health promoting nature of the drug.”

Discussion


Kantakari and Haritaki both belong to Kasahara gana and Haritaki

pathyanam shreshtha48

; therefore Vyaghriharitaki is the best Naimittika Rasayana in

Chronic bronchitis.

It is said for Haritaki that-

Similarly, on the basis of efficacy and safety of Vyaghriharitaki observed in

the patients of Chronic bronchitis (and also what had been mentioned in texts), it can

be said that-

Discussion on Follow up:

During the follow up period of 4 weeks after the active treatment all the

patients maintained ‘status quo’. No patient showed either aggression in the status or

recurrence of the signs and symptoms if they are completely abolished during the

active treatment. This shows the sustained positive effect of the drug on the

Pranavaha srotasa.

“हरीतकी त ुमनुष्याणाां मातवै हहतकाररणी ॥”

“व्याघ्रीहरीतकी त ुक्रॉहनक ब्रॉन्काईरिस ्रुग्णाणाां मातवै हहतकाररणी ॥”

Discussion


REFERENCES

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3 Cha. Chi. 18/4.

4 Su. Su. 21/36.

5 Cha. Ni. 6/3.

6 Deshmukh U P, et.al, Role of Kantakari Avaleha in Kaphaja Kasa (Chronic bronchitis), Shri ayurved

Mahaviyalaya, Nagpur, 1998. 7 Kakati S, et.al, Clinical study of Vyaghriharitaki in Chronic bronchitis vis-à-vis Shaishmika Kasa,

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9 Cha. Vi. 6/11.

10 Cha. Su. 17/62.

11 Cha. Vi. 4/8.

12 Cha. Su. 20/18.

13 Su. Su. 1/25.

14 Harrisons’s principles of internal medicine, edited by Dennis Kasper, Eugene Braunwald, Anthony

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Su. Ut. 1/25. 16

Cha. Vi. 5/23. 17

Cha. Vi. 5/24. 18

Cha. Su. 16/34. 19

Su. Su. 1/25. 20

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Discussion


family physicians, 21

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35 Cha. Su. 10/16-18

36 Cha. Vi. 5/13.

37 A. H. Su. 4/22.

38 Ibid.

39 Cha. Vi. 2.

40Krishnan Kannabiran, Thenmozhi Mohankumar, Vinitha Gunaseker. Evaluation of Antimicrobial

Activity of Saponin Isolated From Solanum Xanthocarpum and Centella asiatica. International

Journal of Natural and Engineering Sciences 2009;3 (1): 22-25. 41

Cha. Chi. 1-1/30-34. 42

Sharma P V, Dravyaguna-vijnana, Vol-II, Chaukhamba Bharati Academy, Varanasi, 1st edition,

Reprint, 1998,pp 756. 43

Ibid. 44

Ibid. 45

Cha. Chi. 28/4. 46

Chakrapani teeka on Cha. Chi. 1-1/30. 47

Cha. Su. 4/16. 48

Cha. Su. 25/40.

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