This is a single centre study wherein the safety and efficacy of combination of Pterostilbene, Garcinol,Anthocyanin will be assessed for weight management in adult male and/or female obese or overweight patients.

Not Applicable

Completed

• Conditions: Health Condition 1: null- For weight management in adult male and/or female obese or overweight patientsHealth Condition 2: E66- Overweight and obesity

• Registration Number: CTRI/2016/07/007089
• 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: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

1. Male or female patients.

2. Age between 20 to 65 years.

3. BMI between > 25 to 40 Kg/m

4. Willing to come for regular follow-up visits.

5. Able to give written informed consent.

Exclusion Criteria

1. Intake of over the counter weight loss agents, centrally acting appetite suppressants in the

previous six months.

2. Pathophysiologic / genetic syndromes associated with obesit y (Cushingâ??s syndrome,

Turnerâ??s syndrome, Prader willi syndrome).

3. Patients with evidence of malignancy.

4. Patients with poorly controlled Hypertension ( > 160/100 mm Hg).

5. Patients 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.

6. Symptomatic patient with clinical evidence of Heart failure.

7. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino

Transferase (AST) and /or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline

Phosphatase (ALP) > 2.5 times upper normal limit or Renal Disorders (defined as Serum

Creatinine > 1.2 mg/dL, Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma

and /or Chronic Obstructive Pulmonary Disease [COPD], or any other condition that may

jeopardize the study.

8. History of HIV and other viral infections.

9. Alcoholics and/or drug abusers.

10. Prior surgical therapy for obesity.

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

12. Pregnant / lactating woman.

13. Patients who participated in any other clinical trial during the past six (06) months.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified