A Randomized, placebo-controlled study to assess the efficacy & safety of the combination of Berberis aristata and Phyllanthus emblica extract supplementation in prediabetic subjects. - NI

Pharmanza 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6月24日

试验速览

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•1. Male and females aged 20 to 60 years (both inclusive); 2. Participants with BMI greater than or equal to 25.00 and less than or equal to 34.9 kg/meter square at screening (Overweight to obese class I); 3. Participants with Hemoglobin A1c (HbA1c) greater than or equal to 5.7 % and less than or equal to 6.4%; 4. Participants with Fasting Plasma Glucose (FPG) between 100-125 mg/dl (both inclusive), 2 hours glucose value between 140-199 mg/dl (both inclusive); 5. IDRS (Indian Diabetics Risk score) less than or equal to 60; 6. Participants providing voluntary, written informed consent to participate in the study.

•1. Participants with type 1 or type 2 diabetes mellitus gestational diabetes or secondary diabetes;
•2. Participants with any other co-morbidity;
•3. Participants treatment of a glucose-lowering or weight loss agent within 90 days before screening;
•4. Participants with elevated liver enzymes AST and or ALT greater than 3 times of the upper normal limit;
•5. Participants with abnormal renal function as measured by eGFR less than 45ml per min per 1.73 meter square;
•6. Participants who had bariatric surgery;
•7. Pregnant or lactating women;
•8. Smokers alcoholics and or drug abusers;
•9. Participants with a known history or ongoing malignancy;
•10. Participants with the treatment of immunosuppressive medications in the past three months;
•11. Participants suffering from major systemic illness necessitating medical care;
•12. Any other reason that can affect the participation of the subject in the study as per investigators discretion.

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