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J.R.A.S. Vol. XXXI, No.3, July -Sept. 10 pp. 15-28 A COMPARATIVE STUDY ON THE EFFECT OF DASHAMOOL TAILA UTTARBASTI AND VIJAYADI VATI IN THE MANAGEMENT OF KASHTARTAVA ~~YDYSMENORRHOEA}ACLINICALSTUDY Anuradha Royl, A. Pandya and B. Ravishankar' Abstract With the advent of new millennium and the herald of high-tech era, women 's status was expected to reach new horizons both socially and physically. But some of the physiological things trouble the lady to make her slow down the race. Such aproblem is Kashtartava (menstrual pain/dysmenorrhoea). Kashtartava is referred as symptom of various Yonivyapadas (gynaecological complaints) in Ayurveda. In this present study, primary dysmenorrhoea is considered as a classicalfeature and apart of disease Kashtartava. The drugs Dashamoola Taila and Vijayadi Vati have been taken for the clinical trial. Because of the side effects due to longstanding administration of antispasmodic, analgesics, PG synthesis inhibitor etc. used in modern medicine and even they do not exert permanent solution, hence we are searchingfor an alternative cure from our ancient heritage which will be cost effective, easily available and better solution to the ailment. I. M.S. (Ayu.), Striroga & Prasuti Tantra, Lecturer & R.M.O., SSMD. Ayurvedic College & Hospital, Moga, Punjab 2. Head, Deptt. of Kaumarbhritya; I.P.G.T. & R.A. Gujarat Ayurved University 3. Head, Deptt. of Pharmacology; I.P.G.T. & R.A.; GujaratAyurved University. 15
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Page 1: A COMPARATIVE STUDY ON THE EFFECT OF ...ayushportal.nic.in/pdf/20101.pdfAnuradha Roy et al. Introduction Most women experience minor psychological and somatic changes for afew days

J.R.A.S. Vol. XXXI, No.3, July -Sept. 10 pp. 15-28

A COMPARATIVE STUDY ON THE EFFECTOF DASHAMOOL TAILA UTTARBASTI

AND VIJAYADI VATI IN THEMANAGEMENT OF KASHTARTAVA

~~YDYSMENORRHOEA}ACLINICALSTUDYAnuradha Royl, A. Pandya and B. Ravishankar'

Abstract

With the advent of new millennium and the herald of high-tech era, women 's

status was expected to reach new horizons both socially and physically. But some

of the physiological things trouble the lady to make her slow down the race. Such

aproblem is Kashtartava (menstrual pain/dysmenorrhoea).

Kashtartava is referred as symptom of various Yonivyapadas (gynaecological

complaints) in Ayurveda. In this present study, primary dysmenorrhoea is

considered as a classicalfeature and apart of disease Kashtartava.

The drugs Dashamoola Taila and Vijayadi Vati have been taken for the clinicaltrial. Because of the side effects due to longstanding administration of

antispasmodic, analgesics, PG synthesis inhibitor etc. used in modern medicine

and even they do not exert permanent solution, hence we are searchingfor an

alternative cure from our ancient heritage which will be cost effective, easily

available and better solution to the ailment.

I. M.S. (Ayu.), Striroga & Prasuti Tantra, Lecturer & R.M.O., SSMD. AyurvedicCollege & Hospital, Moga, Punjab 2. Head, Deptt. of Kaumarbhritya; I.P.G.T. & R.A.Gujarat Ayurved University 3. Head, Deptt. of Pharmacology; I.P.G.T. & R.A.;GujaratAyurved University.

15

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Anuradha Roy et al.

Introduction

Most women experience minorpsychological and somatic changes fora few days preceding menstruation andduring the days. Once the menstruationis over, these menstrual molimina willdisappear leaving behind an anxietyfree well beingness in the lady. Whenshe has painful menstruatio in fullyblown up and exaggerated mannerthen it becomes dificult for her. InToday's era 50% women suffer fromprimary dysmenorrhoea out of which10% become bed ridden during theperiods.

The disease 'Kashtartava' is notdescribed in classics as an individualdisease entity. It is described as asymptom of various Yonivyapadasspecially Udavarta, Vatala, Sannipatikaetc. But in present scenario, looking atits high prevalence rate, it isconsidered as separate diseaseprimarily due to vitiation of Vat a dosha(Apana and Vyana Vayu) whichsimulates the clinical features ofprimary dysmenorrhoea.

From the treatment peint of view,Dashamool Taila Uttarbasti is selectedin one group. It helps to revitalize thehormonal system, giving youthfulnessand stamina to the body. Uttarbasti hasthe added benefit of increasing Ojas,replenishing the hormonal system andpromoting fertility. This treatment alsogives vibrant energy to the femaleorgans and excellent in Vatashamaka.

In another group Vijayadi Vati isselected, which has a direct referencein Bhaishajya Ratnavali as an oraldrug. Both these groups have beencompared with Placebo group, as thedisease 'Kashtartava' has psychosomaticinfluence. Total 55 patients wereregistered, out of which 48 patientshad completed their treatment alongwith the follow up study. All the dataevolved are helpful in lying down aprobable conclusion that intrauterineUttarbasti is giving better effect thanVijayadi Vati oral group.

Materials and Methods

Selection of Drugs

Dashamoola Taila is one of the bestVatashamaka drugs and Bastikarma isthe principal treatment for Vat a as wellas for Yoniroga. Vijayadi Vati isindicated in Kashtarvata. Thus thesetwo drugs are selected for the presentclinical trial as Uttarabasti & oraltherapy respectively.

Preparation of Drugs

Dashamoola Taila - First theDashamuola is dipped in water forover night and next day Kwatha isprepared. This Kwatha along withKalka Dravya is added in Tila Tailaand Sneha is prepared as per standardprotocol.

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A COMPARATIVE STUDy .

Vijayadi Vati - First of all, BhangaSattwa is purified in milk, dried andpowdered. Equal parts of all the otherthree ingredients i.e. Rakta KamalaMoola, Apamarga Moola and KumariSara are mixed well and given Bhavanaofdistilledwater.Then Vatiwere preparedof 1 Ratti () 25 mg) each (BhaishajyaRatnavali/ Yonivyapada/65-6 7).

All these procedures were carriedout in the pharmacy ofT.P.G.T. & R.A.,Jamnagar.

Selection of Cases

A total of 55 patients of Kashtartavawere selected from O.P.D. of T.P.G.T.&R.A., Hospital, G.A.U., Jar-magar,

For Uttarbasti group: Married womenwere selected.

For oral groups: Both married andunmarried were selected.

Criteria ofInclusion

• Patients coming with chiefcomplaint of Kashtartava(primary dysmenorrhoea) withscanty or average amount ofmenses along with associatedsymptoms.

• Age group between 12 - 40years.

Dose, Time and Duration of drugs inthe Patients

• Dashamoola Taila - Uttarbasti(Test), 5 mllday for 3consecutive days aftercessation of menses, 2 cycles.

• Vijayadi Vati- Oral group(Test), 2 Rati twice daily (500rng/day), for 2 months.

• Roasted wheat powder - Oralgroup (Placebo), 250 mg twicedaily (500 mg/day), for 2months.

• Patients suffering for more than2 cycles.

Criteria of Exclusion

• Patients below 12 years andabove 40 years.

• Patients with chronic generalillness.

• Patients with intrauterinecontraceptive devices.

• Menorrhagia

• Any uterine pathology - fibroid,adenomyosis, endometriosis.

Grouping of Patients

In the present study all the patientswere divided into three groups-

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Anuradha Roy et al.

Group-A : Dashamoola Taila -Uttarbasti (Test)- only married women(15 completed cases).

Group-B : Vijayadi Vati - Oral group(Test)- both married & unmarriedwomen (18 completed cases).

Group-C : Roasted wheat powder -Oral group (Placebo)- both married &

unmarried women ( 15 completedcases ).

Parameters for assessment of thedrug response

It has been assessed on the basis ofsubjective and objective improvementin each follow up (after menses) formain symptoms like pain inhypogastrium, low back pain and painin legs , associated symptoms likeYonikandu, Malasanga, Daurbalya,Angamarda, Shirahshula andPindikodwestana as well as signs andsymptoms related with Artavavahasrotas.

Table-IEffect of therapy on Artavavaha Srotasa (Group-A)

Particular No. of Mean %

pts. B.T. I A.T. imp. S.D. S.E. 't' P

Artavakshaya 01 03 01 66.66 0.00(Pramana)Artavakshaya 03 2.67 01 62.551- 0.57 0.33 5.00 <0.05*(Avadhi)

Vandhyatva 05 03 1.8 40.00 1.64 0.73 1.63 >0.10

Kashtartava 15 03 0.77 75.671- 0.79 0.20 10.02 <0.001 **

Maithuna 01 03 01 66.66 0.00Asahishnuta

Observations and Results

Effect of therapy in ArtavavahaSrotasa

Group A showed statistically

significant (t=05.00, P<0.05) inArtavakshaya Avadhi, while highlysignificant (t=10.02, P<O.OOI) resultin Kashtartava (Table- J).

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A COMPARATIVE STUDy .

Table-IIEffect of therapy on Artavavaha Srotasa (Group-B)

Particular No. of Mean %pts. B.T. I A.T. imp. S.D. S.E. 't' P

Artavakshaya(Pramana)

Artavakshaya(Avadhi)

Vandhyatva

Kashtartava

MaithunaAsahishnuta

03 3.0 0.66 77.661' 0.57 0.33 7.00 <0.05*

03 2.8 0.60 78.571' 0.83 0.37 5.87 <0.05*

02

18

3.03.0

3.00 0.00

0.66 68.671' 0.66 0.15 14.44 <0.001**

Group-B showed statisticallysignificant in Artavakshaya Pramana(t=07.00, P<0.05) and ArtavakshayaAvadhi (t=05.87, P<0.05) while,

statistically highly significant(t=14.44, P<0.001) result In

Kashtartava (Table -II).

Table-IIIEffect of therapy on Artavavaha Srotasa (Group-C)

Particular No. of Mean %pts. B.T. I A.T. imp. S.D. S.E. 't' P

Artavakshaya 05 2.60 2.40 7.69 0.44 0.20 1.00 >0.10(Pramana)

Artavakshaya 04 2.50 2.25 10.00 0.50 0.25 1.00 >0.10(Avadhi)

Vandhyatva 01 3.00 3.00

Kashtartava 15 3.00 2.80 6.66 0.41 0.10 1.87 >0.10

MaithunaAsahishnuta

In group C, statistically non in all the particulars (Table-Ill).

significant (P>O.lO) result was observed

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Comparative Effect of Therapy on KashtartavaTable-I V-A

Between Group A and Group C (vide Artavavaha Srotasa)

Groups No. of Mean 0/0

pts. B.T. I A.T. imp. S.D. S.E. 't' p

Group C

Group A

15

15

3.00

3.00

2.80 6.66 0.41 0.10 1.87 >0.10

0.77 75.671' 0.79 0.20 10.02 <0.001 **

Table-IV-BBetween Group B and Group C (vide Artavavaha Srotasa)

Groups No. of Mean %pts. B.T. I A.T. imp. S.D. S.£. 't' P

Group CGroup B

15

18

3.00

3.00

2.80 6.66 0.41

0.66 68.671' 0.66

0.10 1.87 >0.10

0.15 14.44 <0.001**

Table-IV-CBetween Group A and Group B (vide Artavavaha Srotasa)

Groups1

No. of Mean I 0/0

S.E·I1pts. B.T. I A.T. I imp. S.D. 't' P

Group A 15 3.00 0.77 75.671' 0.79 0.20 10.02 <0.001 **

Group B 18 3.00 0.66 68.671' 0.66 0.15 14.44 <0.001 **

In comparative study of the diseaseKashtartava (vide ArtavavahaSrotasa), group A showed statisticallyhighly significant(t=10.02,P<O.OO1)in comparison to group C(t=01.87, P>O.lO). Similarly group Bshowed statistically highly significant(t=14.44, P<O.OOl) in comparison to

Symptoms

Pain in hypogastriumLow back painPain in legs

group C (t=01.87, P>0.10). Whereasboth the group A (t=10.02, P<O.OOI)and group B (t=14.44, P<O.OOl) werefound statistically highly significantbut in comparison group-A provided75.67% and group B 68.67% relief(Table IV-A, IV-B & IV-C).

p

92.661'93.331'74.801'

0.42 0.11 24.47 <0.001**0.4] 0.10 26.19 <0.001**1.04 0.31 06.06 <0.001 **

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A COMPARATIVE STUDy .

Effectoftherapyonmainsymptoms significant in reducing pain Inhypogastrium (t=24.47, P<O.OOI), lowback pain (t=26.19. P<O.OOJ)and painin legs (t=06.06, P<O.OOI)(Table-V).

Table-VIEffect of therapy on main symptoms (Group-B)

The effect of therapy in Group Awas observed statistically highly

Symptoms

Pain in hypogastrium 17

Low back pain

Pain in legs

14

08

2.21 0.71

2.12 0.75

P

78.331' 0.49 0.11 19.69 <0.001**

64.251' 0.64 0.17 8.27 <0.001**

64.621- 0.51 0.18 7.51 <0.001 **

Group-B also showed statisticallyhighly significant result in reducingpain in hypogastrium (t=19.69,

P<O.OOI), low back pain (t=8.27,P<O.OOI) and pain in legs (t=07.51,P<O.OOI) (Table-VI)

Table-VIIEffect of therapy on main symptoms (Group-C)

Symptoms

Pain in hypogastrium 15

Low back pain

Pain in legs

12

06

2.83 2.33

2.33 1.83

P

16.081' 0.83 0.21 2.16 >0.05*

17.66 0.90 0.26 1.91 <0.05

21.46 0.83 0.34 1.46 <0.10

was obtained III reducing pain m

hypogastrium only (Table- VII).In Group-C, only statistically

significant (t=02.16, P<0.05) result

SymptomsA.T. P

Yonikandu 06 0.00 1001- 0.98 0.40 4.56 <0.01**Malasanga 06 0.16 87.201- 0.40 0.16 7.00 <0.01**

Oaurbalya 12 01.00 42.851' 0.45 0.12 5.74 <0.01 **Aruchi 12 0.50 56.391- 0.45 0.13 5.74 <0.01 **

Angamarda 09 0.22 79.201- 0.33 0.11 8.00 <0.01 **Shirahshula 09 0.66 56.741- 0.33 0.11 8.00 <0.01 **

Pindikodwestana 10 0.30 80.001- 0.78 0.24 4.81 <0.01 **

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Anuradha Roy et al.

Effect of therapy on associatedsymptoms

In group-A, Yonikandu (t=04.56,P<O.O 1), Malasanga (t=07.00,P<O.OO 1), Daurbalya (t=05.74,

P<O.OO1), Angamarda (t=08.00,P<O.OOl), Shirahshula (t=08.00,P<O.OO I) and Pindikodwestana(t=04.81, P<O.OO1) were foundstatistically highly significant result(Table- VIU).

Table-IXEffect of therapy on main symptoms (Group-B)

Symptoms No. of Mean %

pts. B.T. I A.T. imp. S.D. S.E. 't' P

Yonikandu 04 1.25 0.50 60.00 0.50 0.25 3.00 >0.05

Malasanga 09 1.77 0.66 62.711' 0.60 0.20 5.54 <0.01 **

Daurbalya 15 1.93 0.93 51.821' 0.53 0.13 7.24 <0.01 **

Aruchi 10 1.20 0.10 91.661' 0.31 0.10 11.00 <0.01 **

Angamarda 08 1.62 0.37 77.161' 0.70 0.25 5.00 <0.01 **

Shirahshula 07 1.85 0.71 61.621' 0.37 0.14 8.00 <0.01**

Pindikodwestana II 2.09 0.45 77.991' 0.67 0.20 8.04 <0.01 **

In group B, symptoms like Pindikodwestana (t=08.04, P<O.OOI)Malasanga (t=05.54, P<O.OOl), and Aruchi (t=-11.00, P<O.OOI) wereDaurbalya (t=07.24, P<O.OOl), found statistically highly significantAngamarda (t=05.00, P<O.OO1), result (Table-IX).Shirahshula (t=08.00, P<O.OOl) and

Table-XEffect of therapy on main symptoms (Group-C)

SymptomsP

Yonikandu 0.00Malasanga 0.00Daurbalya 15.38 0.42 0.13 1.50 >0.10Aruchi 10.93 0.37 0.14 1.00 >0.10Angamarda 25.00 0.46 0.16 1.52 >0.10Shirahshula 23.14 0.54 0.22 2.23 >0.05Pindikodwestana 8.91 0.37 0.14 1.00 >0.10

In group -C, the effect of therapywas found statistically non-significant

(p>O.1 0) (Table-X).

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A COMPARATIVE STUDy .

Table-XIPercentage Relief of the patients in all the three groups

Group -A Group-A Group-A% relief Effect No. of I No. of I No. of I

pts. 0/0 pts. 0/0 pts. 0/0

>75 Cured 08 53.33 08 44.44 00 00.00

51-75 Markedly 05 33.33 04 22.22 00 00.00

improved

25-50 Improved 02 13.33 04 22.22 04 26.66

<25 No improvement 00 00.00 02 11.11 11 73.33

Percentage Relief of the patients inall the three groups

Overall effect of therapy revealedthat in group A, 8 patients (53.33%)had >75% relief, 5 patients (33.33%)were markedly improved and 2patients (13.33%) were improved.

In group-B, 8 patients (44.44%)had >75% relief, 4 patients (22.22%)had marked improvement, samenumber of patients (22.22%) hadimprovement and only 2 patients(11.11%) were having noimprovement.

In group-C, only 4 patients(26.66%) were improved and 11patients (73.33%) were having noimprovement (Table -XI).

Discussion

InAyurvedic classic Kashtartava is

not considered as a separate diseaseentity but described as a symptom ofmany gynaecological disorders. In thepresent study we considered it as anindependent disease, is mainly due toderangement of Vata Dosha, caused byMargavarodha, Dhatukshaya andSwanidana Prakopa.

In this present study, total 48patients were given treatment alongwith follow up study. Maximumnumbers of patients were of the agegroup between 12 - 20 years, fromnuclear families, duration of chiefcomplaints more than 6 years, 40.00%of patients had positive family historywith 27.27% of mother positive.70.91 % had pain only during 1St day ofmenses with 96.36% had pain inhypogastrium and 85.45% in lowback, 83.64% had cramp type of painand 14.55% had infertility.

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Anuradha Roy et al.

It is well established that Til Tailais polyunsaturated fatty acid, whichultimately intensifies the penetrationof oil based substances through the cellmembrane. The cell membrane iscomposed of lipid bilayer, which hasan inherent capability of movement,and this movement is directlyproportional to the temperature. Thismay be the reason to heat the oil in mildtemperature before administration ofUttarbasti. Dashamoola havingShothahara effect, as one patient withcervical erosion and oedematouscervix when given Uttarbasti of itshowed rapid decrease in thesymptom. The oedematous cervixbecame quite normal after three daysof Uttarbasti which can be furtherstudied for.

Significant result was found inPramana of Artavakshaya in group-B,also in group-A. It shows that due toMargavarodha by Vata there wasArtavakshaya. Probably both the testdrugs pacify the vitiated Vataespecially Apana Vayu, the symptomssubsides.

In group-A, 5 patients were havinginfertility and may be due to the actionof'Dashamoola Taila Uttarbasti we got40% results and patients becomepregnant, which is a significantachievement. Out of them, I patientwas of 6 years of infertility and I

having recurrent abortion.

Again in group-A, 1 patient washaving MaithunaAsahishnutva and wegot 66.66% improvement in her.

On main symptoms, highlysignificant results were obtained inboth group -A and B in all thesymptoms and in group-C significantresult was found only in reducing painin hypogastrium. This shows the effectof patient's psychology upon thedisease.

Hence it proves the disease to bepsychosomatic and the drugs to haveproperties of Vatanulomana andVedanasthapana.

On associated symptoms, both groupA and group B had shown statisticallyhighly significant result in reducingmost of the symptoms but group Ashowed better improvement alongwith reducing the symptoms likeAsthisandhi Shoo la, Anidra andGuruta of the body.

Conclusion

Very encouraging result (75.67%)was found in group A (Uttarbasti) inthe main cardinal features than groupB. In group B (Vijayadi Vati) also quiteencouraging result (68.67%) wasfound but there was less effect Inassociated symptoms than group A.

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A COMPARATIVE STUDy .

We got quite good result in the patientsof infertility after the two courses ofUttarbasti of Dashamoola Taila. Theoedematous cervix became quitenormal after three days of Uttarbastisuggesting its Shothahara effect.

In group-C (Placebo) a very smallfraction of patients were having slightimprovement in symptoms whichsuggests the disease to bepsychosomatic in nature. It is just thepsychology of the patient, which hasgiven slight relief in pain due toKashtartava.

Journals

I) The Journal of Pharmacology andexperimental therapeutics. Vol.306, Number 2, August 2003,

American Society forPharmacology and ExperimentalTherapeutics.

2) Gynaecology and Obstetricsupdates, Vol. 2, No.2.

3) Muse (1990) Cyclic Pelvic Pain,Obstetric and GynaecologyClinics of North America, 17(2),427-440.

4) Clinical Evidence, 10 (Dee), 2058-2078,2003.

5) Current Medical LiteratureGynaecology and Obstetrics,Dabur Pharma Ltd.

6) British Journal of Obstetrics andGynaecology (SJOG), 2005,August. 112(8); 1164.

Scoring Pattern of Symptoms (Multidimensional Scoring Pattern)

o Menstruation is not painful and daily activity unaffected.

1 Menstruation is painful and daily activity not affected. No analgesicsrequired.

2 Menstruation is painful and daily activity affected, analgesics were needed.

3 Menstruation is painful, she cannot do even her normal routine work andhas to be absent from class or office during menses. She has to takeanalgesics but have poor effect.

Gradation of Associated Symptoms1. Yonikandu

o No Kandu

1 Occasionally

2 Kandu only 2-3 days (mild to moderate)

3 Kandu more than 3 days (severe)

25

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Anuradha Roy et al.

2. Artava Pramana (Assessment by Pad)

o 6-7 pads/cycle1 4-5 pads/cycle

2 2-3 pads/cycle

3 Spotting or 1pad/cycle

3. Artavakshaya Avadhi

o Duration of menses 4- 7 days.

1 Duration of menses 3 days.

2 Duration of menses 2 days.

3 Duration of menses 1days.

4. Malasanga

o No Malasanga.1 Frequency once in a day, but hard stool pass.2 Frequency of stool alternative day and patient fills difficulty in

defecation.3 Patient can not pass stool without any purgative agent even after 3-4 days.

5. General Evaluating Scale

o Absence pf symptoms1 Mild2 Moderate3 Severe

6. Overall Assessment of TherapyIt is assessed on the basis of percentage of relief obtained

% of relief>7551-7525-50<25

Effect:Cured:Markedly improved: Improved:No improved

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A COMPARATIVE STUDy .

Prof. Sharma P.V.

Vd.Acharya 1.T.

Prof. Sharma P.V.

Prof. Murthy K. R. S.

Prof Murthy K.R.S.

ShuklaG.D.

SatyapaJ

Prof. Sharma P.V.

Shastri A.D.

Prof. Tiwari P.V.

Prof. Singh R. H.

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(Approved on 10-11-2008)

28


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