In this study Garcinol 20% would be compared with an inert substance in reducing the risk of metabolic syndrome in obese individuals.

Phase 3

• Conditions: Health Condition 1: E669- Obesity, unspecified

• Registration Number: CTRI/2020/02/023571
• Lead Sponsor: Sami Labs Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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.

10 Subjects having history of coagulopathies, cardiovascular diseases, congestive heart failure, pancreatitis, lactic acidosis, hepatomegaly with steatosis, motor weakness,

peripheral sensory neuropathy, psychiatric disorder, Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD].

11 Have been diagnosed with an eating disorder, such as anorexia nervosa, bulimia nervosa, binge eating disorder or nocturnal eating disorder.

12 History of any psychiatric disorders like schizophrenia or bipolar disorder.

13 Weight loss (±5%) in last 6 months.

14 Subjects on prolonged ( > 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.

15 Subjects with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and/or Alanine Amino Transferase (ALT), Total Bilirubin,Alkaline Phosphatase (ALP) >2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL for females or >1.4 mg/dL for males and EGFR of 60 or less).

16 History of hypersensitivity to any of the herbal extracts or dietary supplement.

17 Pregnant / lactating woman.

18 Subjects who have completed participation in any other clinical trial during the last three months.

19 Any other condition which the Principal Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 Mean change in measured body weightTimepoint: 1 Mean change in measured body weight (Baseline and Day90)

Secondary Outcome Measures

Name	Time	Method
1 Mean change in calculated BMI <br/ ><br>2 Mean changes in Lipid profile. <br/ ><br>3 Mean change in the glycaemic parameters. <br/ ><br>4 Change in measured body weight. <br/ ><br>5 Mean changes in obesity related serum biomarkers. <br/ ><br>6 Mean change in waist circumference. <br/ ><br>7 Mean change in waist to hip ratio. <br/ ><br>8 Incidence and rate of adverse events. <br/ ><br>9 Exploratory objective - Change in microbial gut flora.Timepoint: 1 Calculated BMI (Baseline and Day 90) <br/ ><br>2 Lipid profile (Screening and Day 90). <br/ ><br>3 Glycaemic parameters (Screening and Day 90). <br/ ><br>4 Body weight (Day 30,Day 60 & Day 90 respectively) <br/ ><br>5 Obesity related serum biomarkers (Baseline and Day 90). <br/ ><br>6 Waist circumference (Baseline and Day 90) <br/ ><br>7 Waist to hip ratio (Baseline and Day 90). <br/ ><br>8 Incidence and rate of adverse events. <br/ ><br>9 Exploratory objective - Change in microbial gut flora (Baseline and Day90).