Comprehensive Evaluation of the Clinical Efficacy of an Anti-Diabetic Polyherbal Formulation

Abstract

Background: There are several clinical studies examining the health advantages of several single medicinal herbs utilized in traditional blood glucose-lowering treatments. But very few or no studies on herbal formulations were made as Polyherbal for the same goal. As a result, it is now necessary to confirm that patients with hyperglycemia can benefit from such Polyherbal medicines as Dolabi. Methods: This prospective open-label, herbal coded test drug-controlled, randomized trial was conducted at the Munshiganj and Dhaka area in Bangladesh. We enrolled 108 male and 104 female patients of 30-70 years with primary and moderate hyperglycemia. They were recruited from the OPD of an Unani & Ayurvedic hospital in Munshiganj and different Unani clinics in Dhaka, Bangladesh after fulfilling the inclusion criteria. Patients were randomly assigned to receive metformin hydrochloride 500 mg two times daily and 2 tablets of Dolabi two times daily by using a random numbers table with the help of an assistant. Blood samples, height, weight, blood pressure, and personal data were recorded—laboratory results were obtained at the study baseline, after 1.5 months and after 3 months of intervention. Results: In the case of the test drug, results showed a significant decrease in blood glucose level between the baseline and after 3 months, in males, it was from 9.83±1.17 to 7.72±1.06 mg/dL for fasting glucose, from 16.60±2.35 to 8.23±1.17 mg/dL for 2 hours PP glucose, from 9.33±1.17 to 7.45±2.03 percent for HbA1c and for Insulin it reduces from 183.10±27.59 to 168.10±29.59 pmol/ L. The control drug metformin hydrochloride also showed a significant decrease in blood glucose level between baseline and after 3 months, in the case of males it was from 9.99±2.52 to 6.97±1.76 mg/dL for fasting glucose, from 17.43±5.05 to 7.89±2.42 mg/dL for 2 hours PP glucose, from 10.43±2.36 to 6.87±1.18 percent for HbA1c and for Insulin it reduces from 198.75±30.61 to 183.75±30.61p mol/L. In the case of females the test drug showed a significant reduction in fasting glucose, 2 hours PP glucose, HbA1c and Insulin between the baseline and after 3 months, it was from 10.02±1.11 to 7.78±0.93 mg/dL, from 16.88±2.21 to 8.16±1.11 mg/dL, from 9.84±1.04 to 7.45±1.03 percent and from 199.47±30.90 to 173.47±30.90 mg/dL respectively. In the case of females, the control drug showed a significant reduction in fasting glucose, 2 hours PP glucose, HbA1c and Insulin between baseline and after 3 months, it was from 10.18±1.92 to 6.71±1.59 mg/dL, from 18.70±3.88 to 7.60±3.74 mg/dL, from 10.58±1.08 to 6.98±1.08 percent and from 200.00±31.83 to 188.00±31.83 mg/dL respectively. Conclusions: We can infer the following from the present study’s findings: The polyherbal formulation Dolabi is able to reduce the blood glucose level. It can be an effective drug for primary hyperglycemic patients.