CTRI/2021/03/032126CompletedPhase 2
A randomized, parallel arm controlled clinical trial to assess safety and efficacy of weight management Gummies supplementation. - Nil
Aesthetic Nutrition Pvt Ltd0 sites90 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 90
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Obese patients (male/female and aged between 20-45 yrs.)
- •BMI between 30 - 37 kg/m2
- •Subjects with or without comorbidities, if comorbidity exists should be on stable prescription and with the following criteria- Hypertension (140/90 mmHg on prescription), Type 2 DM (HbA1C <= 7.5 on prescription)
- •Willing to provide consent
- •Willing for follow up
Exclusion Criteria
- •Subjects with any acute illness requiring immediate medical care.
- •Subjects with Type I DM/Complicated cardiovascular diseases / HbA1C >= 7.5. / History of TIA, Cerebrovascular accident, stroke or any revascularization.
- •Known subjects of hepatic failure/inflammation.
- •Pregnant, breast feeding or planning to become pregnant during the study.
- •Any other condition which proves subject unfit for the study participation
Investigators
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