scholar varun desale desale.pdfcriteria for selection of patients: patients having fasting blood...

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

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