Study to evaluate the effect of Pramehagajakesari Rasa, An Ayurvedic herbo-mineral formulation: Randomized Placebo Controlled Study in Type 2 Diabetic Patients with Secondary Failure to Oral Hypoglycemic Drugs

Dr Sunil S Borkar0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Subjects already diagnosed with Type II Diabetes mellitus with secondary failure to oral hypoglycemic drugs.
•2.Subjects having HbA1c value between 6 - 9 % at screening.
•3.Subjects having Fasting Plasma Glucose 125-250 mg/dl and Post prandial Plasma Glucose not more than 300mg/dl at screening.
•4.Subjects of either sex in the age group of 18 to 70 years, both inclusive.
•5.Subjects willing to follow the procedures as per the study protocol and voluntarily signing informed consent form.

•1.Subjects of Type I Diabetes Mellitus
•2.Known cases of Severe/ Chronic hepatic or renal disease.
•3.Subjects having any active malignancy.
•4.Subjects giving history of significant cardiovascular event <12 weeks prior to screening.
•5.Subjects having known major complications of Diabetes like Ketoacidosis, nephropathy, Neuropathy, Retinopathy and Diabetic wounds.
•6.Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C or HIV.
•7.Subjects having active metabolic or gastrointestinal disease that may interfere with nutrient absorption, metabolism, or excretion, excluding Diabetes.
•8.Pregnant and Lactating female Subjects
•9.Known hypersensitivity to any of the ingredients used in study drug.
•10.Subjects using any other investigational drug within 1 month prior to recruitment or currently participating in any other clinical trial.
•11.Any other condition due to which subjects are deemed to be unsuitable by the investigator for reason(s) not specifically stated in the exclusion criteria.

发起方

Dr Sunil S Borkar