Department of Rasashastra and Bhaishajya Kalpanaincluding drug Research,
Institute for Post Graduate Teaching & Research in Ayurveda, Gujarat Ayurved University, Jamnagar, Gujarat, India
Scholar
Varun Desale
IntroductionNumber of metals and minerals are used in Ayurvedic
therapeutics .
Naga Bhasma is one of them, which is beneficial inMadhumeha along with number of other diseases.
Use of improperly prepared Naga Bhasma leads tocomplications.
Jarana is mentioned as pre procedure for Marana of Nagasince medieval period.
Marana with Parada yoga is considered as superior thanother methods of Marana (Marana with Ariloha).
Cont…Diabetes mellitus is likely to be a leading cause of morbidity
and mortality in near future.
Diabetes is fast gaining the status of a potential epidemic inindia withmore than than 62 million diabetic individualscurrently diagnosed with disease.1
1 Kumar A,Goel MK, Jain RB,Khanna P, Chaudhary V. India ntowards diabetes control :issues. Australas Med J.2013;6(10):524-31[PMC free article][ PubMed]
Aims and objectives:
To evaluate the role of Naga Bhasma in themanagement ofMadhumeha.
To compare the effect of Naga Bhasma prepared by twodifferent methods in the management ofMadhumeha.
Naga Bhasma 1 (NB 1):
Naga bhasma prepared by marana with Parada andGandhaka but without jarana
Naga Bhasma 2 (NB 2):
Marana with Manahshila (Ariloha) preceded with Jaranaprocess by Ashwattha.
MATERIALS AND METHODS
Test Drugs
Criteria for selection of patients:
Patients having fasting blood sugar level ≥ 126 mg/dl or 2hr plasma glucose level ≥ 200 mg/dl up to 600 mg /dl.
classical symptomatology of Madhumeha have beenselected from the O.P.D. and I.PD. Of I.P.G.T. & R.A., Hospital,G.A.U., Jamnagar.
Age group of patients -30 to 90 years.
Clinical proforma has been prepared incorporatingselected symptoms.
Haematological ( Hb., TLC, DLC, ESR), Urine (routine,microscopic)
Biochemical (BSL, LFT, RFT, Lipid profile) investigationswere carried out.
Criteria for Exclusion of Patients:
All patients of diabetes mellitus receiving insulin.
Patients having chronic complications of diabetesmellitus type2
i. Micro vascular: Retinopathy, Neuropathy &nephropathy.
ii. Macro vascular: Coronary Artery Disease, Peripheralvascular disease & Cerebrovascular disease.
Grouping and posology:
Group A: NB-I(naga bhasma 1) 60 mg BD
Group B: NB-II ( naga bhasma 2)60 mg, BD
Group C: 60mg of starch .
Where haridra and amalaki was taken as 95mg ineach group.
Haridra and amalaki were added as diluents anddose of the drug was decided as per capsule twicedaily so that 120mg of nagbhasma (i.e.NBI & NBII)is administered per day.
Route of drug administration: Oral
Duration of drug administration: :28 days.
Follow up period: 28 days
Criteria for assessment:
Improvement in the signs and symptoms based on bothAyurvedic and modern parameters.
Investigations conducted before and after treatment.
Statistical analysis:
Mean, percentage relief, S.D., S.E., ‘t’ and ‘p’ values were calculated.
Paired ‘t’ test was used for calculating the ‘t’ value in the paired data.
For comparison of the results with placebo control group, unpaired ‘t’ test was used.
For comparison of results in objective parameters, “Analysis of Variance Test (ANOVA)” was applied.
Cardinal symptoms and laboratory investigations:
For the assessment of the effect of the therapy followingchief complaints and biochemical parameters wereselected:- Prabhuta Mutrata, Avila Mutrata, Trishnadhikya,Hasta-Pada-Tala Daha, Kara- Pada Suptata, Daurbalya,Pindikodweshtana, Klaibya;
Blood for Hb%, total leucocyte count, differential leucocytecount,erythrocyte sedimentation rate, urine for routine andmicroscopic examination and biochemical investigations(fasting blood sugar,post-prandial blood sugar, blood urea,serum creatinine, lipidprofile and serum insulin [in selectedpatients]) was performed.
Assessment of overall effect of the therapy:
The result obtained from individual patient wascategorized according to the following grades:
Control of the disease : 100% relief
Marked improvement : ≥ 75% relief
Moderate improvement : ≥ 50% upto 75% relief
Mild improvement : ≥ 25% upto 50% relief
No improvement : < 25% relief
Groupwise distribution of patients:-
Group Registered Completed Drop out
A 23 17 06
B 22 18 04
C 11 09 02
Total 56 44 12
OBSERVATION AND RESULTS
Effect of therapy
Gr.
Mean±SEM %
Change‘t’ significanc
eB.T A.T Change
prabhuta mutrata A 1.88±0.16 0.56±0.18 1.31±0.12 70.00 10.97** H.S
B 1.77±0.18 0.65±0.19 1.12±0.19 63.33 05.90** H.S
C 2.00±0.27 1.75±0.31 0.25±0.16 12.50 01.53 N.S
Avil Mutrata: A 1.44±0.13 0.38±0.13 1.06±0.06 73.91 17.00** H.S
B 1.18±0.10 0.18±0.10 1.00±0.12 85.00 08.25** H.S
C 1.13±0.13 1.13±0.13 0.00±0.00 00.00 00.00 N.S
Trishnadhikya; A 1.75±0.17 0.44±0.18 1.31±0.12 75.00 10.97** H.S
B 1.53±0.19 0.59±0.17 0.94±0.22 61.54 04.32** H.S
C 1.50±0.27 1.25±0.25 0.25±0.16 16.67 01.53 N.S
Kara-pada-tala
Daha
A 2.00±0.16 0.31±0.12 1.69±0.18 84.38 09.59** H.S
B 1.88±0.17 0.29±0.11 1.59±0.12 84.38 12.91** H.S
C 1.83±0.31 1.33±0.33 0.50±0.22 27.27 02.24 N.S
On cardinal symptoms
Kara-pada-
Suptata
A 1.47±0.13 0.33±0.16 1.13±0.17 77.27 6.86** H.S
B 1.79±0.21 0.21±0.16 1.57±0.20 88.00 7.78** H.S
C 1.67±0.33 1.67±0.88 0.00±0.58 00.00 0.00 N.S
Daurbalya A 1.47±0.13 0.6±0.16 1.13±0.13 65.39↓ 8.5** HS
B 1.82±0.12 0.59±0.15 1.24±0.16 67.74↓ 7.67** HS
C 1.63±0.26 1.38±0.32 0.25±0.16 15.39↓ 1.53 NS
Pindikodweshtan
a
A 2.25±0.25 0.75±0.25 1.50±0.50 66.67↓ 3.0 NS
B 2.00±0.32 0.8±0.2 1.2±0.2 60.00↓ 6.0** HS
C 2.00±0.67 1.33±0.67 0.67±0.67 33.33↓ 1.0 NS
Klaibya A 1.17±0.17 0.50±0.22 0.67±0.21 57.44↓ 3.13* NS
B 1.67±0.33 0.33±0.33 1.33±0.33 80.00↓ 4.00 NS
C 0.00±0.00 0.00±0.00 0.00±0.00 00.00 0.00 NS
Gr.
Mean±SEM%
Change‘t’ significa
nceB.T A.T Change
Cont…
Parameters Group Mean±SEM %
Change‘t’
Signific
anceB.T A.T Change
BSL-F A 189.81±15.93 156.88±13.92 32.94±12.13 17.35↓ 2.72* HS
B 203.00±13.98 169.61±17.32 33.39±11.33 16.45↓ 2.97* HS
C 171.11±15.31 161.11±11.91 10.00±9.52 05.84↓ 1.05 NS
BSL-pp A 279±17.97 233.44±16.82 45.56±11.83 16.33↓ 3.85** HS
B 271.56±16.85 229.78±20.69 41.78±13.69 15.39↓ 3.05** HS
C 242.11±17.90 219.78±18.58 22.33±11.23 09.22↓ 1.99 NS
serum
cholesterol
A 204.07±10.34 194.86±8.99 10.21±10.47 5.01↓ 0.98 NS
B 183.11±6.85 186.44±7.00 -3.33±10.23 1.82↓ 0.33 NS
C 205.89±11.30 193.22±11.34 12.67±7.75 6.15↓ 1.64 NS
Effect on Biochemical parameters
Serum
Triglyceride
A 148.71±16.49 133.79±14.81 14.93±13.69 10.04↓ 1.09 NS
B 163.41±30.50 139.77±14.95 23.65±21.33 14.47↓ 1.11 NS
C 167.33±22.04 159.33±28.47 08.00±13.31 04.78↓ 0.60 NS
HDL A 37.00±1.07 40.64±1.59 -3.64±1.62 9.85↑ 2.25* HS
B 38.53±0.84 40.29±1.55 -1.77±1.60 4.58↑ 1.10 HS
C 40.22±1.00 39.56±1.37 0.67±1.73 1.66↓ 0.39 NS
SGOT A 22.75±0.87 22.13±1.07 0.63±1.43 2.75↑ 0.44 NS
B 24.00±2.07 26.08±2.41 -2.08±2.10 8.65↑ 0.99 NS
C 23.33±1.86 30.22±4.49 -6.89±4.72 29.52↓ 1.46 NS
SGPT A 21.69±1.17 24.25±2.99 -2.56±2.67 11.82↑ 0.96 NS
B 21.15±1.34 29.00±3.49 -7.85±2.97 37.09↑ 2.64* HS
C 25.11±1.94 25.78±3.37 -0.67±2.89 2.66↑ 0.23 NS
Parameters Group Mean±SEM %
Change
‘t’ Signifi
canceB.T A.T Change
Cont...
Serum
Alkaline
phosphatase
A 45.65±1.97 55.06±5.94 -9.38±5.96 20.52↑ 1.57 HS
B 47.39±2.46 59.15±7.35 -11.77±8.04 24.84↑ 1.46 NS
C 46.11±2.62 53.22±2.19 -7.11±2.77 15.42↑ 2.57* NS
Serum
bilirubin
A 0.73±0.08 0.76±0.09 -0.03±0.05 4.31↑ 0.69 HS
B 0.67±0.06 0.79±0.07 -0.44±0.07 18.39↑ 1.81 NS
C 0.57±0.04 0.56±0.04 0.01±0.04 1.96↓ 0.32 NS
Blood Urea A 25.19±1.58 21.31±1.40 3.88±1.54 15.39↓ 2.52* HS
B 21.22±1.57 21.67±1.58 -0.44±2.07 2.09↑ 0.22 NS
C 20.67±1.95 21.11±1.39 -0.44±1.71 2.15↑ 0.26 NS
Serum
Creatinine
A 0.96±0.03 0.92±0.04 0.04±0.04 3.92↓ 1.07 HS
B 0.88±0.04 0.93±0.05 -0.04±0.04 4.64↑ 0.96 NS
C 0.93±0.04 0.88±0.03 0.06±0.02 5.95↓ 3.16* NS
Parameters Gro
up
Mean±SEM %
Chang
e
‘t’ Signific
anceB.T A.T Change
Cont. . .
Serum
protein
A 7.18±0.10 7.12±0.09 0.06±0.13 0.87↓ 0.50 NS
B 7.22±0.08 7.2±0.10 0.02±0.14 0.21↓ 0.11 NS
C 7.17±0.07 7.22±0.11 -0.06±0.12 0.87↑ 0.45 NS
Serum
Albumin
A 4.01±0.12 3.97±0.05 0.04±0.13 1.09↓ 0.34 NS
B 3.99±0.07 4.17±0.08 -0.18±0.14 4.43↑ 1.29 NS
C 4.12±0.05 4.08±0.10 0.04±0.12 1.08↓ 0.37 NS
Parameters Grou
p
Mean±SEM %
Chang
e
‘t’ Signific
anceB.T A.T Change
Cont…
Paramete
r
Grou
p
Mean±SEM %
change
‘t’ Statistical
significan
ceB.T A.T Change
Hb A 12.65±0.45 12.43±0.41 0.22±0.16 1.73↓ 1.37 NS
B 12.21±0.43 12.21±0.30 0.00±0.37 0.00 0.00 NS
C 12.48±0.43 12.43±0.48 0.13±0.23 1.07↓ 0.58 NS
ESR A 25.88±3.75 19.75±3.65 6.13±2.51 23.67↓ 2.44* HS
B 18.35±3.10 12.47±1.61 5.88±2.90 32.05↓ 2.03 HS
C 23.33±6.52 26.44±6.31 -3.11±4.73 13.33↑ 0.66 NS
Effect of test drugs on haematological parameters
Chief complaints Mean±SEM %change ‘t’
GroupA GroupB GroupC Gr.A Gr.
B
Gr.A Gr.B
Prabhuta Mutrata 1.31±0.12 1.12±0.19 0.25±0.16 424.0↓ 348↓ 05.3*
*
4.03**
Avila Mutrata 1.06±0.06 1±0.12 0.00±0.00 -- -- 17.67
**
7.83**
Trishnadhikya 1.31±0.12 0.94±0.22 0.25±0.16 424.0↓ 276.
0↓
04.27
**
2.76*
Kara-pada-tala
Daha
1.69±0.18 1.59±0.12 0.5±0.22 238.0↓ 218.
0↓
04.19
**
5.63**
Kara-pada suptata 1.13±0.17 1.57±0.20 0.00±0.58 -- -- 01.87 2.28*
Daurbalya 1.13±0.13 1.24±0.16 0.25±0.16 352.0↓ 396.
0↓
04.27
**
4.91**
Pindikodweshtana 1.5±0.5 1.2±0.2 0.67±0.67 123.88
↓
79.1
1↓
00.99 1.00
Klaibya 0.67±0.21 1.33±0.33 0.00±0.00 -- -- 3.19*
*
3.39**
Effect of test drugs on chief complaints in comparison to placebo control group;
Mean±SEM %change ‘t’
GroupA GroupB GroupC GrA GrB GrA GrB
Hb 00.22±00.2 00.00±00.3
7
0.13±0.23 069.23↓ 100.00 0.32 0.36
ESR 06.13±02.5 05.88±02.9
0
-3.11±04.73 297.10↓ 289.1↓ 1.73 0.61
BSL-F 32.94±12.1 33.39±11.2
3
10.00±09.5
2
229.40↓ 233.9↓ 1.49 1.44
BSL-pp 45.56±11.8 41.78±13.6
9
22.33±11.2
3
104.00↓ 087.1↓ 1.42 1.69
Sr.cholesterol 10.21±10.5 -3.33±10.23 12.67±07.7
5
019.42↓ 126.3↑ 0.19 1.08
Sr.Triglyceri
de
14.93±13.7 23.65±21.3
3
8.00±13.31 086.63↓ 195.6↓ 0.36 0.40
Sr.HDL -3.64±01.6 -1.77±01.60 0.67±01.73 643.30↑ 364.2↑ 1.82 1.44
Effect of test drugs on haematological and biochemicalparameters in comparison to placebo control group;
SGOT 0.63±01.4 -2.08±02.10 -6.89±04.72 109.10↓ 069.8↑ 1.53 0.68
SGPT -2.56±02.7 -7.85±2.97 -0.67±2.89 282.09↑ 1071.6↑ 0.48 2.54*
ALP -9.38±05.9 -11.77±8.04 -7.11±2.77 031.93↑ 65.54↑ 0.35 2.09
Sr.Bilirubin -0.03±00.1 -0.12±0.07 0.01±0.04 400.00↑ 1300↑ 0.63 2.11*
Blood urea 3.88±0.15 -0.44±2.07 -0.44±1.71 981.82↓ 00.00 1.88 0.74
Sr.creatinine 00.04±00.0 -0.04±0.04 0.06±0.02 003.33↓ 166.7↑ 0.45 1.79
Sr.protein 00.06±00.1 00.02±0.14 -0.06±0.12 200.00↓ 133.3↓ 0.68 0.60
Sr.Albumin 00.04±00.1 -0.18±0.14 0.04±0.12 000.00 550.0↑ 0.00 1.68
Mean±SEM %change ‘t’
GroupA GroupB GroupC GrA GrB GrA GrB
Cont…
ResultsGr.A Gr.B Gr.C Total
No. % No. % No. % No. %
controlled 00 00 01 02.27 00 00 01 02.27
Markedly
Improved03 6.82 6 13.64 00 00 09 20.46
Moderately
Improved12 27.27 09 20.46 02 04.55 23 52.57
Mildly
Improved 02 4.55 01 02.27 02 04.55 05 11.36
Unchanged 00 00 01 02.27 05 11.36 06 13.64
Total
patients17 38.64 18 40.91 09 20.46 44 100.0
Overall effect of therapy
Kapha-Vata-Meda dominated Dosha accumulate in Bastithat is a Mahamarma.In this study Maximum patients werefrom age group 50-70. This age shows dominancy of VataDosha. Maximum number of patients (58.93%) was male.
In the study 89.29% of patients were taking Diwaswapa(table 6.7). It leads to Vikrita Kapha Vriddhi and obstructionof Vatawhich are the main components of Samprapti.
78.57% patients had chronicity above 1 yr. Decrease in ESRin both drug treated groups may represent decrease inchronic infections Thus it may be concluded that NagaBhasmamay enhance immunity.
Discussion
After starting the test drug, their average fasting bloodglucose was reduced by 32.94 and 33.39 mg/dl in Gr. A andGr. B respectively and average decrease in 2 hr plasmaglucose was 45.56 and 41.78 mg/dl in Gr. A and Gr. Brespectively .
The decrease in blood urea level denotes decreasedcatabolism of proteins. It also implies increased functioningability of liver as well as kidney.
Mild to moderate decrease in S. triglyceride level was seenin both drug treated groups. Both of these may implyMedoghna and lekhana Karma of Naga Bhasma.
Clinically, both the samples of Naga Bhasma areeffective antihyperglycemic and HDL increasing drug.
Comparing both Naga bhasma samples on clinicalparameters , Naga Bhasma prepared by using paradaand gandhaka as a media is more efficacious
CONCLUSION
AcknowledgementI would like to sincerely thank
Prof .P K Prajapati
Dr. Patgiri
Dr.Galib
Dr.Bedarkar
Dr. Praveen Tate
The audience
