A clinical study to see the effect of some Ayurvedic formulations in the management of Obesity.

Phase 2

• Conditions: Health Condition 1: null- Obesity

• Registration Number: CTRI/2012/03/002527
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences CCRAS

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: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

1. BMI >=30 kg/m2 and < 40 kg/m2

2. Willing and able to participate in the study for 16 weeks.

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, Prader willi 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. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.)

8. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome,

Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.

9. Symptomatic patient with clinical evidence of Heart failure.

10. 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.

11. Alcoholics and/or drug abusers.

12. Prior surgical therapy for obesity

13. H/o hypersensitivity to any of the trial drugs or their ingredients.

14. Pregnant / lactating woman.

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified