A Randomized, multi-center, Open labeled, Comparative, Prospective Clinical Study To Evaluate Efficacy and Safety of Yesaka Liquid as an Add-on therapy to Oral Hypoglycemic Agent (OHA) in Type 2 Diabetic Patients. - NI

Simandhar Herbal Pvt Ltd0 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

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•1.Subjects suffering from Type 2 Diabetes Mellitus for more than one year, and stabilized on mono/ polydrug anti-diabetic therapy for at least last 3 months.
•2.Subjects having HbA1C value 7-11% (both inclusive) at screening.
•3.Subjects having Fasting Plasma Glucose between 126 -252 mg/dl (both inclusive) at screening.
•4.Subjectâ??s ECG not demonstrating any signs of uncontrolled arrhythmia / acute ischemia and X- ray chest not showing any active lesion of tuberculosis.
•5.A urine pregnancy test is required for all female subjects unless subject has had a hysterectomy, tubal ligation, or is > 2 years post menopause.
•6.Subjects willing to follow the procedures as per the study protocol and voluntarily signing informed consent form

•1.Subjects on insulin therapy.
•2.Subjects suffering from type-1 DM or types of Diabetes mellitus other than Type-2
•3.Subjects with known history of chronic hepatic or renal disease.
•4.Subjects with known history of active malignancy.
•5.Subjects with known history of significant cardiovascular event 12 weeks prior to randomization.
•6.Subjects with known history of major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds.
•7.Subjects with known history of chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
•8.Subjects with known history of active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
•9.History of Use of any other investigational drug within 1 month prior to randomization
•10.Known history of hypersensitivity to ingredients used in study drug
•11.Pregnant and Lactating females.
•12.Any other conditions which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results

发起方

Simandhar Herbal Pvt Ltd