CTRI/2020/02/023571
Not yet recruiting
Phase 3
A prospective, randomized, double-blind, placebo controlled clinical trial to evaluate the efficacy and safety of Garcinol 20% in reducing the risk of metabolic syndrome in obese individuals.
Sami Labs Limited0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sami Labs Limited
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1 Male and/or female subjects aged between 21 to 55 years both inclusive.
- •2 BMI greater than or equal to 29 Kg/m2and less than or equal to 40 Kg/m2\.
- •3 Willing to take up the walking exercise for a span of 30 minutes daily for 5 days in a week and follow the recommended diet throughout the study.
- •4 Subjects agree to maintain a diary on food consumption and exercise.
- •5 Able to give written informed consent.
- •6 Willing to come for regular follow\-up visits.
Exclusion Criteria
- •1 Intake of prescribed drugs in Ayurveda, Homeopathy, Naturopathy, Allopathy etc. or prior surgery for obesity in the previous six months.
- •2 Pathophysiologic/genetic syndromes associated with obesity (Cushingâ??s syndrome,Turnerâ??s syndrome, Prader\-Willi syndrome).
- •3 Alcoholics
- •4 Subjects with evidence of malignancy.
- •5 Subjects having history of diabetes (Type I or Type II); with the fasting blood glucose \>\=126 mg/dl and HbA1c \> 6\.5%
- •6 Subjects with history of clinically diagnosed Hypertension and with BP \> 140 / 90 mm of Hg.
- •7 Subjects diagnosed with thyroid disease, on medications for underactive or overactive thyroid and with TSH \> 6 mIU/L.
- •8 Subjects on lipid lowering drugs.
- •9 Subjects having history of underlying inflammatory arthropathy, septic arthritis,
- •inflammatory joint disease, gout, pseudo gout, Pagetâ??s disease, joint fracture,acromegaly, fibromyalgia, Wilsons disease,Ochronosis, hemochromatosis, heritable arthritic disorder or collagen gene mutations or rheumatoid arthritis.
Outcomes
Primary Outcomes
Not specified
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