A Double blind, Multi-center, Randomized, Prospective, Interventional, Placebo controlled, Clinical study to Evaluate Efficacy and Safety of Yesaka Plus Tablets in patients diagnosed with Type 2 Diabetes mellitus - 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: 2024年3月4日

试验速览

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•1.Patients diagnosed with type 2 diabetes mellitus for not more than one year and those are not on any oral hypoglycemic agent/insulin (regular basis).
•2.Patients having HbA1C value between 6.5-8.5% (both inclusive) at screening.
•3.Patients having Fasting Plasma Glucose between 126 -250 mg/dl (both inclusive) at screening.
•4.Patients having postprandial glucose not more than 350 mg/dl at screening
•5.Patient’s ECG does not demonstrate any signs of uncontrolled arrhythmia / acute ischemia.
•6.A negative urine pregnancy test for all female patients unless patient has had a hysterectomy, tubal ligation, or is > 2 years post menopause.
•7.Patients willing to follow the procedures as per the study protocol and voluntarily signing informed consent form

•1.Patients already on regular OHAs or on insulin therapy.
•2.Patients suffering from type-1 DM or types of Diabetes mellitus other than Type-2
•3.Patients with known history of chronic hepatic or renal disease.
•4.Patients with known history of malignancy.
•5.Patients with known history of significant cardiovascular event 12 weeks prior to randomization.
•6.Patients with known history of major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds.
•7.Patients with known history of chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
•8.Patients 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 Patients at risk or will influence the conduct of study or interpretation of results

发起方

Simandhar Herbal Pvt Ltd