Efficacy and Safety of a Polyherbal Unani drug as an Adjuvant Therapy in type-2 diabetes mellitus: a double blind, Randomized, Placebo Controlled Study

Background This double-blind, randomized, placebo-controlled study was conducted to assess the efficacy and safety of a polyherbal Unani drug as adjuvant therapy in Patients with Type-2 Diabetes who were inadequately controlled with Metformin monotherapy. Methods Patients who had inadequate glycaemic control (HbA1c between 7% to 10%) despite Metformin therapy were randomized into Unani Adjuvant therapy (n=40) and placebo (n = 38) groups. Patients were administered either Unani drug or Placebo at a dose of 02 capsules (each capsule = 500 mg) twice daily in addition to Metformin (500 mg twice daily) therapy. The primary endpoint was the change in glycosylated haemoglobin (HbA1c) levels from the baseline to week 12. Result There was a statistically significant decrease in HbA1c levels from the baseline in the Unani drug group (-1.89 ± 0.05 %, p=.001) compared with the placebo group (-0.53 ± 0.20 %, p= 0.166) at week 12. Compared with the Placebo group, Unani drug significantly decreased fasting plasma glucose levels (-26. 34 ± 11.73, p= 0.002 vs -4.82 ± 2.63 mg/dl, p= 0.089) and postprandial plasma glucose (-60.02 ± 10.18 mg/dl, p= 0.001 vs -18.70 ± 2.06 mg/dl, p= 0.039). Conclusion Unani polyherbal drug as an add on therapy to Metformin in patients with type 2 diabetes who were not at their goal for glycaemic control with Metformin monotherapy produced significant reduction in HbA1c, FPG and PPG levels. Unani drug (or Placebo) add on therapy with Metformin was well tolerated, and showed an overall safety profile similar to placebo.