In this study CALEBIN-A would be compared with an inert substance for its effectiveness and safety, in weight reduction in obese individuals and management of risk factors that increase chance of developing heart disease, stroke and diabetes.

Not Applicable

Conditions: Health Condition 1: E669- Obesity, unspecified

Registration Number: CTRI/2021/09/036495

Lead Sponsor: Sami Sabinsa Group Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. IDF (International Diabetes Federation) 2006:

Waist Ã¢â?°Â¥ 90 cm (men) or Ã¢â?°Â¥ 80 cm (women) along with the presence of minimum two or more of the following:

a. Fasting blood glucose greater than equal to 5.6 mmol/L (100 mg/dl) or diagnosed diabetes

b. HDL cholesterol < 1.0 mmol/L (40 mg/dl) in men, < 1.3 mmol/L (50 mg/dl) in women or drug treatment for low HDL-C

c. Blood triglycerides > 1.7 mmol/L (150 mg/dl) or drug treatment for elevated triglycerides

d. Blood pressure > 130/85 mmHg or drug treatment for previously diagnosed hypertension.

2. Male and/or female subjects aged between 30 to 65 years (both inclusive) with valid age proof.

3. BMI (Ã¢â?°Â¥) greater than or equal to 28 kg/m2 and less than or equal to 35 kg/m2.

4. Willing to take up regular physical activity (for example: walking for a span of 30 minutes daily for 5 days in a week).

5. Subjects willing to agree for blood draws as per the protocol.

6. Able to give written informed consent.

7. 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 (CushingÃ¢â?¬•s syndrome, TurnerÃ¢â?¬•s syndrome, Prader-Willi syndrome).

3. Subjects who disagree to avoid drinking alcohol during study period.

4. Subjects with diagnostic history of malignancy.

5. Fasting Blood Glucose Ã¢â?°Â¥ 150 mg/dl and HbA1c > 7%.

6. Subjects with history of clinically diagnosed Hypertension and with BP > 160 / 100 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, PagetÃ¢â?¬•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 Disorder [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 3 months.

14. Subjects on prolonged ( > 4 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 six months.

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