Ayurvedic study for the treatment of Obesity

Phase 2

Recruiting

• Conditions: Obesity

• Registration Number: CTRI/2015/09/006150
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences

Brief Summary

Sthoulya (obesity is a condition in which there is an excessive accumulation of fat in the body.  This disease is metabolic disease generally occurs in affluent societies. It is associated with increased mortality by predisposing to the development of  diseases like Diabetes mellitus, Hypertension, Atherosclerosis, Heart disease, Arthritis, Infertility etc.

Obesity is most prevalent in middle age, but it can occur at any stage of life.It is highprevalent in socio economic group. There are certain professions in which physical exertion is low are more prone to obesity. female are more affected than males. Endocrine factors and energy imbalance are also responsible for the obesity.



Obese patients having 20% excess weight than desirable weight according to height, sex, and age of both male and female patients will be selected from O.P.D/ I.P.D of the Institute as per Inclusion and Exclusion criteria. The cases will be selected randomly in two groups. First group patients will be studied with classical Ayurvedic drugs Navaka guggulu (Bhaishjya Ratnavali 39/43)1gm TDS and Brihat Manjishtadi Kwatha (AFI Part I PAge 59) 50 ml TDS Second group with Trushnadi guggulu(Bhava Prakash Uttarakhada 3) gms TDS and Ayaskriti(AFI part I Page 6) ml TDS for  weeks. Assesment will be done on every fortnight with clinical parameters, BMI, WHR and Edmonton Obesity Scoring Systems(EOSS). Laboratory investigation will be carried out before and after completion of 12 weeks treatment. The sample size of the study is  240(120 for each centre) ie 60 in eachgroup and the total duration of the study is 2 years.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-21
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 240

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

• 1.Age below 25 years and above 60 years 2.Obesity secondary to or associated with Hypothyroidism, Hyper tension, Diabetes mellitus, Hyperlipidemia or Cushing’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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Obesity in EOSS (Edmonton obesity scoring system)	Total Study Period-2 years | Preparation-3 months | Recruitment-18 months | Statistical Analysis-3 months

Secondary Outcome Measures

Name	Time	Method
Waist Hip Circumference	BMI

Trial Locations

Locations (2)

National Ayurveda Research Institute for Vector Borne Diseases,; 🇮🇳 Krishna, ANDHRA PRADESH, India

National Research Institute of Ayurvedic Drug Development; 🇮🇳 Kolkata, WEST BENGAL, India

National Ayurveda Research Institute for Vector Borne Diseases,

🇮🇳Krishna, ANDHRA PRADESH, India

Dr T Maheswar

Principal investigator

9441415266

mahesh_rri@yahoo.co.in