A Randomized, Double-Blind Clinical Trial Of Poly Herbal Traditional Decoction For The Management Of Type 2 Diabetes In Comparison With Standard Western Treatment

Abstract

Diabetes mellitus type 2 (Mathumekam) is a major health concern in the 21st century. Despite enormous advancements in contemporary science, there is a lack of reasonably safe and efficient medications available its management. The objective of this study was to evaluate the effectiveness of Poly Herbal Traditional Decoction containing 10 herbs namely, Senna auriculata (Root & bark), Cissampelos pareira (root), Ficus racemosa (bark), Terminalia arjuna (bark), Acacia arabica (bark), Syzygium cumini (bark), Curcuma longa (rhizome), Terminalia chebula (fruit pulp), Phyllanthus emblica (dry fruit), Terminalia bellirica (fruit pulp) in the management of Diabetes Mellitus Type 2 (DMT2). It was a double-blind, Randomized Control Trial conducted on 100 participants of DMT2 inadequately controlled by diet and exercise. The test drug was given to group-A participants (n=50) 5g added with 100ml (1 tumbler) boiled water for 10-15 minutes for 12 weeks and the standard western therapies (a drug alone or in combination with other hypoglycemic Western medicines based on the blood glucose level). The patients in group B (n=50) were received a placebo in addition to standard western treatment therapies. Primary outcome of the study was reduction of Glycosylated Hemoglobin (HbA1c) from baseline after three months, secondary outcomes were reduction of Fasting Blood glucose Level (FBG) and changes of Signs and symptoms of diabetes mellitus. The overall efficacy of the formulation was assessed in terms of reduction in fasting blood glucose level during the study period. At the end of the study, mean fasting blood glucose was reduced to 119.04 ±11.52 mg/dL and 176.90 ±13.91 mg/dL in test group and control group respectively. A reduction in mean fasting blood glucose was higher in Group I showing the overall therapeutic effectiveness of the test drug indicating that daily administration of Poly Herbal Traditional Decoction and standard Allopathic medical therapies for 03 months resulted in significant reductions of FBG. Similarly, Group I showed better improvement of the assessed diabetic signs and symptoms such as polydipsia, polyuria, polyphagia, fatigue, burning sensation in palm and soles in comparison to Group II during the study period. Moreover, the mean HbA1c (%) in Group I and Group II at baseline was 7.47 ±0.70 and 7.39 ±0.66 whereas at the end of 12 weeks of study the level of glycated haemoglobin in Group I and Group II was reduced to 5.03 ±0.53 and 6.79 ±0.51 respectively. No adverse events were reported throughout the trial period. This study concludes that the test drug (Poly Herbal Traditional Decoction) was effective in T2DM in reducing FBG and HbA1c significantly in diabetic mellitus patients at 12 weeks of treatment.