A manufacturing process of Swarna Makshika Bhasma and its clinical trial in Diabetes type 2 Patients.
- Conditions
- Type 2 diabetes mellitus without complications,
- Registration Number
- CTRI/2015/08/006114
- Lead Sponsor
- IPGT and RA
- Brief Summary
Themain aim of the study was to assess comparative efficacy of *Swarnamakshika* *bhasma* along with *TriphalaGhana* on *Madhumeha* (Diabetesmellitus). Clinical study has obtained Institutional Ethics Committee clearance(PGT/7-A/Ethics/2014-2015/1538/2.14) and is registered at Clinical TrialRegistry of India, ICMR, New Delhi, vide CTRI-2015/08/006114. It is arandomized double blind study. Computer generated Randomization method was usedfor generating randomization sequence. Patients of 30 to 60 years of agefulfilling inclusion criteria were enrolled in the study irrespective of theirsex, religion etc. from OPD and IPD of Rasashastra and Bhaishajya Kalpana ofIPGT & RA, GAU, Jamnagar. Detailed history was taken and physicalexamination was done on the basis of a special proforma incorporating signs andsymptoms of the disease. Patients having fasting blood sugar level ≥ 126 mg/dlor PPBS level ≥200mg/dl were enrolled in study and also assessed to explore thecondition of the patients before and after treatment. Other investigationscarried out were routine hematological (including TLC, DLC, Hb, ESR, Total RBC)and biochemical investigations (including S. Creatine, SGOT, SGPT, AlkalinePhosphatase etc.) to exclude any other pathology.
The two trial drugs prepared in thelaboratory were blinded as trial drug - A and B. Hence the selected patientswere randomly placed into two groups:
Group - A : *Triphala Ghana* with Placebo
Group - B : *SwarnamakshikaBhasma* along with *Triphala Ghana*
Dose : 500 mg twice daily before food
Anupana : Honeyorally
Duration : 56 days (8weeks)
Follow-up : 28 days (4weeks)
Table- : Total number of patients registered in three groups
| | | | |
| --- | --- | --- | --- |
|**Group**
**No. of patients**
|**Total Registered**
**Completed**
**Discontinued**
|**Group-A**
56
51
05
|**Group-B**
54
50
04
|**Total**
110
101
09
Total 110 patients wereregistered in the study. 101 patients completed the treatment. Nine patientsdiscontinued the trial, as three patient of group A and two patients of group Bshowed incompatibility to come at regular intervals during treatment course.Two patients from group A and group B each refused for routine investigationsat regular interval and discontinued treatment.
Majorityof the patients (45.45%) belongs to the age group of 51-60 years, and females (59.09%), while 97.27% patients were married. About 49.09% patients were of *Vata Kaphaja Prakruti*, 52.73% patients having chronicity of1-4 years and 57.27% were using some of the allopathic medicines.
All the registered patients presented with *Prabhutamutrata* (Polyuria) 67.27%*,* 62.73% with *Daurbalya* (Weakness), 59.09% with *Pindikodweshtana* (Cramps in calf muscles) and 55.45%with *Kshudhdhikya* (Polyphagia)54.54% with *Trishnadhikya* (Polydypsia); *Kara-Pada-tala Daha* (burning sensation in palms & soles) was observed in 46.36% patients,42.73% with *Kara-Pada Suptata*(Numbness in palms & soles), 35.45% whichindicates dominancy of *Vata* in thedisease. Statistically highly significant (p<0.001) results were obtained ingroup B on cardinal symptom like *PrabhutaMutrata, Kara-Pada-Tala Daha, Kara-Pada Suptata, Gala talu shosha, Shrama,Pindikodweshtana, and Daurbalya* the % change was also more in Group-B. Reduction in symptom *Prabhuta mutrata* and *Daurbalya* was significant (p<0.05) ingroup A. Rest of all cardinal symptoms were insignificantally decrease in bothof the Groups. However, on comparative assessment drug B showed bettersymptomatic relief (statistically insignificant) than test drug A.
Glycemiccontrol is one of the most important therapeutic challenges in present daydiabetes care. Group A showed statistically insignificant (p>0.05) decreasein FBS and PPBS. While Group B showed statistically significant (p<0.05)decrease in FBS and PPBS. In group B 18.79% decrease in urine sugar level wasobserved it was statistically significant (p<0.05). While in group Astatistically insignificant decrease of 1.87% in urine sugar was noted(p>0.05). Results indicate that sugar in urine is well managed by group B. When compared by chi-square test drug Bshowed better improvement in FBS, PPBS, Urine sugar parameters while test drugA produced insignificant effect. Based on these objective parameters, as far asglycemic control is concerned drug B can be considered marginally better thantest drug A.
Insignificantdecrease in Sr. Cholesterol, Sr. Triglycerides were noted in Group B whileInsignificant decrease in Sr. Cholesterol in Group A. As both the drugsexhibited anti –hyperlipidemic / lipid lowering effect (on cholesterol,triglycerrides, LDL and VLDL), hence it can be concluded that, both of the testdrugs could be preferred in obese diabetics and *Sthula Pramehi* as described by Acharya Charaka.
**Overalleffect of therapy:**
Analyzing above results it was observed that Group-Bmore effective than Group-A in management of *Madhumeha* (type 2 diabetes mellitus). When compared by chi-squaretest drug B was observed better in relief in symptoms thereby improving qualityof life of patients.
**Comparison between overall effects of therapy of both the groups**
In group A out of 51 completed patients among them29.41% were unimproved, 37.25%were mildly improved, 29.41% were moderatelyimproved and 3.92% of patients showed marked improvement at the end oftreatment period. In group B out of 50 completed patients among them 6.00% wereunimproved, 12.00% were mildly improved, 38.00% were moderately improved and44.00% of patients showed marked response after completion of treatment period.
**Adverse drug reaction:**
No undesirable effects were observedin patients during the clinical trials. There was no undesirable druginteraction between trial drug and modern oral antidiabetic drug (Biguanidesand Sulphonyurease+ Biguanides).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
- 1.Patients having classical symptomatology of Madhumeha (Prabhutamutrata, Avilamutrata etc) will be selected from O.P.D. and I.P.D. of I.P.G.T. & R.A., Hospital, Jamnagar.
- 2.Symptoms of Diabetes (Polyuria, Polydypsia, Polyphagia and Weight loss.) 3.Both the sexes having Age between 30 years to 60 years.
- 4.Patients having Blood sugar – FBS ≥ 126 mg/dl – PPBS ≥ 200 mg/dl.
- 1.Age below 30 and above 60 years.
- 2.Malignant and accelerated Hypertension.
- 3.Patients having chronic complications of Diabetes Mellitus a.Microvascular: Retinopathy, Neuropathy, & Nephropathy.
- b.Macrovascular: Coronary artery disease, Peripheral vascular disease & Cerebro-vascular disease.
- c.Other chronic debilitating diseases like STD etc.
- 4.Pregnant women.
- 5.Lactating mothers.
- 6.Secondary Diabetes mellitus.
- 7.Patients of any other severe illness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method It is expected that the trial drugs will exert a significant action over blood sugar level. up to 8 weeks
- Secondary Outcome Measures
Name Time Method By maintaining the helthy level of BSL, The drug will control conditions associated with Madhumeha(DM TYPE II) like Polyuria, Polydypsia, Polyphagia and Weight loss etc. up to 8 weeks.
Trial Locations
- Locations (1)
Institute For Postgraduate teaching and Research in Ayurveda
🇮🇳Jamnagar, GUJARAT, India
Institute For Postgraduate teaching and Research in Ayurveda🇮🇳Jamnagar, GUJARAT, IndiaDr Krushnkumar TaviadPrincipal investigator9427222898drkrishnat@gmail.com