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Clinical Trials/CTRI/2020/02/023571
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Sami Labs Limited

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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