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

Abstract

Efficacy and Safety of a Polyherbal Unani drug as an Adjuvant Therapy in type-2 diabetes mellitus: a double-blind, Abstract 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 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.