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Ayurvedic study for the treatment of Obesity

Clinical Evaluation of Certain Ayurvedic Formulations in the Management of Sthoulya (Obesity)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/09/006150
Enrollment
240
Registered
2015-09-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Obesity

Interventions

Intervention1: Group I Navaka Guggulu, Brihat Manjishtadi Kashaya Group II Trushanadi Guggulu, Ayaskriti: Group-I 1. Navaka guggulu (Bhaishajya ratnavali 39/43) Dose : 1 gm TDS Dosage form :

Sponsors

Central Council for Research in Ayurvedic Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex with age above 25years and below 60 years. 2. Obese patient having 20% excess weight than desirable weight according to height, sex and age / age adjusted BMI above 85th percentile (Indian standard) 3. WHR- Waist Hip circumference Ratio > 0.95 in males & > 0.8 in females.

Exclusion criteria

Exclusion criteria: 1. Age below 25 years and above 60 years 2. Obesity secondary to or associated with Hypothyroidism, Hyper tension, Diabetes mellitus, Hyperlipidemia or Cushingâ??s syndrome. 3. Pregnancy and lactation. 4. Patients who cannot report in person once in 2 weeks in the OPD 5. Patients with poorly controlled Hypertension ( >160/100 mmHg) 6. Patients with poorly controlled Diabetes Mellitus having Hb A1C of > 8 7. Patients who have a past history of Arterial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. 8. Symptomatic patient with clinical evidence of Heart failure. 9. Known HIV & Viral Hepatitis positive cases 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, smokers, and/or drug abusers 12. H/o hypersensitivity to any of the trial drugs or their ingredients 13. Patients who have completed participation in any other clinical trial during the past six months. 14. Any other condition which the Investigator thinks may jeopardize the study.

Design outcomes

Primary

MeasureTime frame
Obesity in EOSS (Edmonton obesity scoring system) Timepoint: Total Study Period-2 years Preparation-3 months Recruitment-18 months Statistical Analysis-3 months

Secondary

MeasureTime frame
Waist Hip Circumference BMI Changes in SymptomsTimepoint: Treatment period - 12 weeks Follow up 2 weeks

Countries

India

Contacts

Public ContactDr Maheswar Thugutla

Central Council for Research in Ayurvedic Sciences

mahesh_rri@yahoo.co.in08662402535

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026