An Open Labeled, Multicenter, Prospective, Clinical Study to Evaluate the Suitability for Consumption of Chyawanprakash in Controlled Type II Diabetic Patients. - NI

Dabur Research Development Centre DRDC0 sites120 target enrollmentStarted: TBDLast updated: November 24, 2021

Trial Snapshot

No summary available.

•1.Subjects suffering from Type II Diabetes Mellitus for more than one year, and stabilized on either exercise/diet regimen or mono / polydrug 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 of female gender or non-pregnant, non-lactating females, at least six weeks postpartum. 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.
•5.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.

•1.Subjects on Insulin therapy.
•2.Subjects suffering from Type I DM or type of Diabetes mellitus other than Type II.
•3.Subjects having known hepatic or renal disease.
•4.Subjects having an active malignancy.
•5.Subjects giving history of significant cardiovascular event < 12 weeks prior to randomization.
•6.Subjects having known major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds.
•7.Subjects having a chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
•8.Subjects having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
•9.Subjects using any other investigational drug within 1 month prior to recruitment
•10.Known hypersensitivity to any of the ingredients used in study drug
•11.Pregnant and Lactating females.
•12.Subjects participating in another Clinical trial
•13.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.

Sponsor

Dabur Research Development Centre DRDC