CLINICAL TRIAL ON OBESITY WITH TWO AYURVEDIC DRUGS LEKHANIYA GANA KASHAYA AND AROGYAVARDHINI GUTIKA

Phase 3

Completed

• Conditions: Health Condition 1: E660- Obesity due to excess calories

• Registration Number: CTRI/2022/03/040819
• Lead Sponsor: CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-03-05
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1.Obese subjects of BMI ( >25 to 39.9 kg/m2)

2.Obese patients of either sex and of age between 18 – 45 years.

3.Willing to participate in the study

Exclusion Criteria

1.Obesity due to secondary causes – Hypothyroidism, PCOD, Cushing’s syndrome etc.

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

3.Patients with uncontrolled Diabetes Mellitus having HbA1C >8%.

4.Patients who are on corticosteroids, Ca++ channel blockers, anti-psychotics, antidepressants, anti-cholinergic, anti-epileptics, immune-suppressants, Hormonal replacement therapy or any other drugs that may have an influence on the outcome of the study.

5.Patients with the H/O significant systemic illness which might interfere with the compliance of the trail drug (Rheumatoid arthritis, Tuberculosis, Inflammatory Bowel Disease etc.).

6.Patients who have a past history of Cardiac Arrhythmia, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.

7.Symptomatic patients with clinical evidence of congestive cardiac failure.

8.Known cases of HIV and AIDS & Patients suffering with malignancy.

9.Patients with concurrent serious hepatic disorders (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT) > 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)

10.Women who are planning for conception / pregnant or lactating.

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

12.Any other condition which the Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Symptomatic improvements assessed by means of VAS <br/ ><br>2.Changes in BMI <br/ ><br>Timepoint: At end of 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1. Changes in percentage of body fat assessed by DEXA Scan <br/ ><br>2. Change in Lipid Profile <br/ ><br>3. Changes in HbA1c <br/ ><br>Timepoint: baseline and endpoint i.e. 12 weeks