A Two Arm, Randomized, Open Labeled, Prospective, Multi-Centre, Clinical Study to Evaluate Efficacy and Safety of Dabur Ratnaprash Sugar Free (DRDC/2015/003) in Controlled Type II Diabetic patients

Dabur India Limited0 个研究点目标入组 120 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 suffering from Type II Diabetes Mellitus for more than one year, and stabilized on either exercise/diet regimen or mono / poly drug oral anti-diabetic therapy.
•2. Subjects having HbA1c value below 8% at screening.
•3. Subjects having Fasting Plasma Glucose 90 -150 mg/dl (both inclusive) and postprandial glucose in the range of 110-180 mg/dl at screening.
•4. Subjects in the age group of 18 to 70 years, both inclusive.
•5. 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 > 2 years postmenopausal.
•6. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form

•1. Subjects on Insulin therapy.
•2. Known cases of Severe/Chronic hepatic or renal disease.
•3. Known subject of any active malignancy.
•4. Subjects giving history of significant cardiovascular event < 12 weeks prior to randomization.
•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. Known subjects of 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
•10. Pregnant and Lactating females.
•11. Subjects currently participating in any other Clinical study
•12. Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria

发起方