Dr. M Komala, Dr. Mohd Aleemuddin Quamri, Dr. Raja Ram and Dr. M Ashok
Background and objectives: The number of people with diabetes is growing rapidly worldwide. Long term hyperglycaemia leads to macro and microvascular complications, resistance to the conventional treatment and increase in complications communicates to have alternative treatment for controlling hyperglycaemia and reducing complications of Diabetes mellitus. Hence a clinical trial conducted to evaluate the efficacy of Unani Formulation in comparison with BGR 34 in Type 2 Diabetes Mellitus.
Methods: This study was conducted as single blind, randomized, controlled clinical trial on 45 patients of diabetes test (n=25) and control (n=20) for 56 days. Test group received Unani formulation and control group BGR-34® twice a day before meal.
Efficacy of both groups was assessed as subjective parameters weekly and objective parameters FBS, PPBS fortnightly and HbA1c before and after treatment.
Results: Subjective parameters polyuria, polyphagia, nocturia, polydypsia, tiredness, weight loss and blurring of vision were found to be highly significant in both the groups, by using Dunn Friedman Test with post test with P<0.0001. Inter group comparison was done using Kruskall-Wallis test and P< 0.0001 was observed in polyuria at 56th day from baseline whereas, objective parameters using repeated ANOVA for intra group analysis and Mann Whitney U test inter group analysis for FBS was found suggestive significant in control group (p=0.0496) in comparison with test group (p=0.082), and PPBS, HbA1c were found insignificant clinically with p >0.05 in both the group.
Interpretation & Conclusion: This comparative analyses of test versus control drugs was not found significant objectively, but clinically significant in subjective parameters. But throughout the study there will be no significant adverse effect observed.