CTRI/2022/12/047809Not yet recruiting未知
A Randomized, placebo controlled study to assess the efficacy & safety of nutritional and phytoconstituents supplementation in prediabetic subjects - Nil
Meyer Organics Pvt Ltd0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Male and female subjects of 30 to 60 years of age (both inclusive)
- •2. BMI >=28.00-<=35 kg/m2 at screening. (Overweight to obese)
- •3. Hemoglobin A1c (HbA1c) >=5.7 % and <=6.4%.
- •4. Fasting Plasma Glucose (FPG) between 100-125 mg/Dl both inclusive.
Exclusion Criteria
- •1. Subjects with type 1 or type 2 diabetes mellitus (T2DM), gestational diabetes (GDM), or secondary diabetes;
- •2. Treatment with glucose lowering agent (s) within 90 days before screening.
- •3. Subjects with elevated liver enzymes AST and/or ALT >3 times of the upper normal limit
- •4. Subjects with abnormal renal function as measured by eGFR <45ml/min/1.73m2
- •5. Subjects with BMI more than 35Kg/m2
- •6. Subjects who had a bariatric surgery.
- •7. Pregnant or lactating women.
- •8. Smokers/Alcoholics and/or drug abusers.
- •9. Subjects with known history or ongoing malignancy.
- •10. Treatment with immunosuppressive medications in past three months.
- •11. Subjects suffering from major systemic illness necessitating medical care.
- •12. Any other reason which can affect the participation of the subject in the study as per investigatorâ??s discretion.
Investigators
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