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

Y. Shamsi, Manju Sharma, A. Jabeen, Wasi Akhtar
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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.
复方Unani药物辅助治疗2型糖尿病的疗效和安全性:一项双盲、随机、安慰剂对照研究
摘要背景:本研究采用双盲、随机、安慰剂对照的方法,对二甲双胍单药治疗控制不充分的2型糖尿病患者,评价一种复方Unani药物作为辅助治疗的疗效和安全性。方法将经二甲双胍治疗后血糖控制不达标(HbA1c在7% ~ 10%之间)的患者随机分为Unani辅助治疗组(n=40)和安慰剂组(n= 38)。与安慰剂组相比,Unani药物显著降低了空腹血糖水平(-26。(34±11.73,p= 0.002 vs -4.82±2.63 mg/dl, p= 0.089)餐后血糖(-60.02±10.18 mg/dl, p= 0.001 vs -18.70±2.06 mg/dl, p= 0.039)。结论:在二甲双胍单药治疗未达到血糖控制目标的2型糖尿病患者中,Unani多药治疗可显著降低HbA1c、FPG和PPG水平。Unani药物(或安慰剂)加二甲双胍治疗耐受性良好,总体安全性与安慰剂相似。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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