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

CLINICAL EVALUATION OF LEKHANIYA GANA KASHAYA AND AROGYAVARDHINI GUTIKA IN THE MANAGEMENT OF MEDOROGA (OBESITY)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/03/040819

Enrollment

100

Registered

2022-03-04

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E660- Obesity due to excess calories

Interventions

None listed

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
1. Symptomatic improvements assessed by means of VAS 2.Changes in BMI Timepoint: At end of 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks	—

Secondary

Measure	Time frame
1. Changes in percentage of body fat assessed by DEXA Scan 2. Change in Lipid Profile 3. Changes in HbA1c Timepoint: baseline and endpoint i.e. 12 weeks	—

Countries

India

Contacts

Public ContactDr Bhavya BM

MS Regional Ayurveda Research Institute, CCRAS, Jaipur

vdsuhaschaudhary@gmail.com9427073351

Outcome results