An Open Label, Single Arm, Multi-center, Prospective, Clinical Study to Evaluate Efficacy and Safety of Ayubes Capsules in Type II Diabetes Mellitus - NI

Welex Laboratories Pvt Ltd0 个研究点目标入组 32 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 with newly diagnosed Type II Diabetes Mellitus or known case of Diabetes mellitus not more than one year
•2. Subjects having HbA1c value between 6-8 % at screening (both inclusive).
•3. Subjects having Fasting Plasma Glucose 125-250 mg/dl (both inclusive) and Postprandial glucose not more than 300 mg/dl at screening.
•4. Subjects of female gender or non-pregnant, non-lactating females. A urine pregnancy test is required for all female subjects of childbearing potential unless subject has had a hysterectomy, tubal ligation, or is greater than 2 years Postmenopausal.
•5. Subjects willing to follow the procedures as per the study protocol and Voluntarily signing informed consent form.

•1. Subjects of Type 1 Diabetes.
•2. Known cases of Severe/Chronic hepatic or renal disease.
•3. Subject having any active malignancy.
•4. Subjects giving history of significant cardiovascular event less than 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 diseases that may interfere
•With nutrient absorption, metabolism, or excretion, excluding diabetes.
•8. Subjects using any other investigational drug within 1 month prior to recruitment
•9. Known hypersensitivity to any of the ingredients used in study drug

发起方

Welex Laboratories Pvt Ltd