PHARMACEUTICAL STUDY OF SWARNA MAKSHIKA BHASMA AND ITS CLINICAL EFFICACY IN MADHUMEHA (DM TYPE-II)

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).