This is a randomized, double blind, placebo controlled, three group study in which the safety and efficacy of Curcuma caesia will be compared with Cyperus rotundus and Curcuma caesia for weight management in obese or overweight patients.

Not Applicable

Completed

• Conditions: Health Condition 1: null- Obese or overweight patientsHealth Condition 2: E66- Overweight and obesity

• Registration Number: CTRI/2016/01/006487
• 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: 60

Inclusion Criteria

1 Male and or female patients.

2 Age between 20 to 65 years.

3 BMI between 25 to 40 kg/m2.

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 obesity (Cushingâ??s syndrome, Turnerâ??s syndrome, Praderwilli syndrome).

3 Patients with evidence of malignancy.

4 Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%).

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

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

7 Symptomatic patient with clinical evidence of Heart failure.

8 Patients 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), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study.

9 History of HIV and other viral infections.

10 Alcoholics and/or drug abusers.

11 Prior surgical therapy for obesity.

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

13 Pregnant / lactating woman.

14 Patients who have completed participation in any other clinical trial during the past six (06) months.

15 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 Decrease in body weight and Body mass index <br/ ><br>2 Change in leptin & adiponectin levels <br/ ><br>3 Change in DEXA analysis <br/ ><br>4 Decrease in Total Cholesterol, LDL Cholesterol, VLDL Cholesterol and Triglycerides <br/ ><br>5 Increase in HDL Cholesterol <br/ ><br>6 Improved anthropometric measurements (waist circumference, waist: hip ratio) <br/ ><br>7 ESR and HS CRP <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 1 Decrease in body weight and Body mass index <br/ ><br>2 Change in leptin & adiponectin levels <br/ ><br>3 Change in DEXA analysis <br/ ><br>4 Decrease in Total Cholesterol, LDL Cholesterol, VLDL Cholesterol and Triglycerides <br/ ><br>5 Increase in HDL Cholesterol <br/ ><br>6 Improved anthropometric measurements (waist circumference, waist: hip ratio) <br/ ><br>7 ESR and HS CRP <br/ ><br> <br/ ><br> <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1 Any reports of adverse or serious adverse events <br/ ><br>2 Abnormal vital signs <br/ ><br>3 Abnormal laboratory investigationsTimepoint: 1 Any reports of adverse or serious adverse events(Day 30, Day 60 & Day 90) <br/ ><br>2 Abnormal vital signs(Screening,Day 0,Day 30,Day 60 & Day 90) <br/ ><br>3 Abnormal laboratory investigations(Screening & Day 90)