CTRI/2020/09/027807
Completed
Phase 3
A randomized, multi-center, double blind, parallel assignment, placebo- controlled, two arm study to assess safety and efficacy of iSlim flat tummies for weight management in adult male and/or female obese or overweight subjects.
IndusViva HealthSciences Pvt Ltd0 sites70 target enrollmentStarted: TBDLast updated:
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- IndusViva HealthSciences Pvt Ltd
- Enrollment
- 70
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1\.Adult male and non\-pregnant females aged 18 to 55 years
- •2\.BMI ââ?°Â¥ 25 kg/m2 to 40 kg/m2 with one or more of the metabolic risk factors (waist circumference ââ?°Â¥80 cm, fasting glucose ââ?°Â¥100 mg/dL, BP
- •Ã¢â?°Â¥130/85 mmHg, HDL\-cholesterol \<50 mg/dL OR controlled diabetes, hypertension, dyslipidemia with medications)
- •3\.Able to comply with all required study procedures and schedule.
- •4\.Able to comply and willing to follow the prescribed diet plan.
- •5\.Willing and able to give written informed consent.
- •6\.Subjects who agree to stop from using supplements during the study duration time
- •7\.Subjects willing to refrain from any obesity treatment
- •8\.Subjects willing to follow the suggested diet plan
Exclusion Criteria
- •1\. Participantswithuncontrolledhypertension(systolicblood pressure (SBP) \>180 mmHg, or diastolic blood pressure (DBP) \>120 mmHg)
- •2\. Participants with hepatic disease (aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \>3 x institutional upper limit of normal) or renal disease (serum creatinine \>2\.0 mg/dL)
- •3\. Participants with significant cardiovascular disease or stroke
- •4\. Participants with history of seizures
- •5\. Endocrine disease such as hypothyroidism or Cushing syndrome
- •6\. History or existence of neurological or psychological disease (schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, bulimia and so on)
- •7\. Use of medication within the past 3 months that could have an effect on weight (appetite suppressant, laxative, oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine or medication having an effect on absorption, metabolism and excretion).
- •8\. A know history or present condition of allergic response to any pharmaceutical products and supplements.
- •9\. History of weight reduction surgery, bariatric surgery and so on
- •10\. Weight reduction \> 10% within the past 6 months
Investigators
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