Complementary Therapeutic Effect of Polyherbal Supplement (Gasca D™) on Newly Diagnosed Type 2 Diabetic Patients on Lifestyle Modification: A Randomised Cohort Clinical Trial

S. I. Ibrahim, N. Kabir, D. Ibrahim, Amina Umar Abdullahi, Chedi Bashir, Y. Fakhraddeen
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Abstract

Our previous studies have shown that Gasca D™; a polyherbal formulation made from three well known antidiabetic plants in Nigeria, possess anti-hyperglycemic, body weight and blood lipid lowering potentials in rats. In view of this, the present study was therefore designed to evaluate the complementary therapeutic efficacy of Gasca D™ supplementation with lifestyle modification in a clinical setting. The randomized cohort trial was conducted in sixty (60) newly diagnosed type 2 diabetic patients on life style modification as first-line therapy who willingly volunteered to participate. The subjects that satisfy our inclusion criteria were randomly assigned into Gasca D™ (GG) and lifestyle (LG) groups. The GG group received 2000 mg Gasca D™ capsules daily over a twelve weeks period whereas the LG group received none. Biochemical estimates were conducted on subjects to evaluate the safety and efficacy of the polyherbal supplement at the end of the intervention period. Mean fasting blood sugar (FBS) showed a decrease of 23.4% (p < 0.05) in the GG group contrary to a 9.6% mean FBS observed in the LG (p < 0.05) group. Variation in glycosylated hemoglobin (HbA1c) was in line with that of FBS. Safety of Gasca D™ was demonstrated by a normal renal and liver function profile in both groups. Our finding suggests that, Gasca D™ can successfully be used as an effective and safe complementary nutraceutical for the control of hyperglycemia in type 2 diabetic patients on life style modification.
多草药补充剂(Gasca D™)对新诊断的2型糖尿病患者生活方式改变的补充治疗效果:一项随机队列临床试验
我们之前的研究表明,Gasca D™;这是一种由尼日利亚三种著名的抗糖尿病植物制成的多草药配方,在大鼠身上具有抗高血糖、降体重和降血脂的潜力。鉴于此,本研究旨在评估Gasca D™补充剂与生活方式改变在临床环境中的补充治疗效果。随机队列试验在60例新诊断的2型糖尿病患者中进行,这些患者自愿参加生活方式改变作为一线治疗。符合纳入标准的受试者被随机分为Gasca D™(GG)组和lifestyle (LG)组。GG组在12周的时间内每天服用2000毫克Gasca D™胶囊,而LG组则没有服用。在干预期结束时,对受试者进行生化评估,以评估多草药补充剂的安全性和有效性。GG组平均空腹血糖(FBS)下降23.4% (p < 0.05), LG组平均空腹血糖下降9.6% (p < 0.05)。糖化血红蛋白(HbA1c)的变化与FBS一致。两组患者的肾功能和肝功能均正常,证明Gasca D™的安全性。我们的研究结果表明,Gasca D™可以成功地作为一种有效和安全的补充营养保健品,用于控制2型糖尿病患者的高血糖,改变生活方式。
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