An exploratory, randomized, double blind, parallel, placebo controlled study to investigate the blood sugar lowering effect of EN-DM-02, EN-DM-04 and EN-DM-05 in comparison with placebo in drug naïve/medication free patients with Type II Diabetes Mellitus under Protocol ID: VL/090707/EN/DM/EN-DM-05.

Exotic Naturals0 个研究点目标入组 48 人开始时间: 待定最近更新: 2021年11月24日

研究概览

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•1) Patients with Type 2 diabetes mellitus, with FBS 150-180 mg/dl and HbA1c of 7% to 8.5 % who are either drug ?naïve or have been medication free for at least 3 months
•2) Body Mass Index between 18.5 and 30 kg/m2
•Patients willing and able to follow diet and exercise regime for the study duration

•1) Patients requiring insulin / having diabetic complications
•2) Hypertensive patients with BP ≥ 160/100 mm of Hg
•3) Patients on fibrates and niacin (which are known to affect blood sugar levels)
•4) Pregnant and nursing women
•5) Patients unwilling to practice contraception.
•6) Serious hepatic or renal impairment (Liver Dysfunction as evidenced by SGPT level of 1.5 X ULN and Renal Dysfunction as evidenced by Creatinine level of 1.5 X ULN
•7) Significant cardiovascular co-morbidities, e.g. symptomatic heart failure, uncontrolled hypertension, history of ischemic heart disease (as evident from ECG), history of stroke and/or Transient Ischemic Attack.
•8) Debilitating neurological or psychiatric disorders
•9) Known hypersensitivity or allergy to one or more of the herbal ingredients
•10) Recent (within last 3 months) participation in a clinical trial.
•11) Subjects otherwise judged by the investigator or sub-investigator to be inappropriate for inclusion in the study

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