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CTRI Number  CTRI/2024/01/061008 [Registered on: 01/01/2024] Trial Registered Prospectively
Last Modified On: 29/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the improvement in liver disease activity in patients with fatty liver disease using lifestyle intervention in form of Yoga and Exercise 
Scientific Title of Study   Efficacy of Yoga in patients with Metabolic dysfunction associated Steatotic Liver Disease - An open label, Non- Inferiority, Randomised Controlled Trial 
Trial Acronym  Nil  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sunil Taneja 
Designation  Associate Professor, Department of Hepatology 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Room no 36, Hepatology Office, Nehru Hospital Extension Block, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9592160444  
Fax    
Email  drsuniltaneja@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Balaraja S 
Designation  Senior Resident 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Room no 36, Hepatology Office, Nehru Hospital Extension Block, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9738447671  
Fax    
Email  balarajas015@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Balaraja S 
Designation  Senior Resident 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Room no 36, Hepatology Office, Nehru Hospital Extension Block, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9738447671  
Fax    
Email  balarajas015@gmail.com  
 
Source of Monetary or Material Support  
Postgraduate Institute of Medical Education and Research, Chandigarh 
 
Primary Sponsor  
Name  Postgraduate Institute of Medical Education and Research 
Address  Room 36, Hepatology Office, Nehru Hospital Extension Block, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr BALARAJA S  Postgraduate Institute of Medical Education and Research  Department of Hepatology, PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH 		 9738447671

balarajas015@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Postgraduate Institute of Medical Education and Research Chandigarh Institutional Ethics Committee(Intramural)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K760||Fatty (change of) liver, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard Medical Therapy  Physical Exercise 150-200minutes/week, Hypocaloric Diet(30% reduction) spanned over three meals per day Duration: 6months 
Intervention  Yoga and Hypocaloric Diet  Yoga of 60 minutes/day, Hypocaloric Diet(30% reduction) spanned over three routine meals per day Duration: 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients with MASLD: defined by the presence of hepatic steatosis on ultrasound or using CAP parameters (of Fibroscan) together with the presence of at least one of five cardiometabolic criteria after ruling other causes of hepatic steatosis.
2)Overweight and obese patients as per Asia-Pacific criteria (BMI ≥ 23 and ≥ 25Kg/m2) respectively.
3)All patients must be on stable doses of medical therapy for hypertension or diabetes for atleast 6 weeks before the study start date.
4)Be willing and able to participate in the full program.
5)Be willing and able to functionally participate in all activities set as part of the intervention.
6)Be able to complete all day-to-day activities and instrumental activities of daily living independently, completely without assistance from others.
7)Consent to participate in study.
 
 
ExclusionCriteria 
Details  1)Patients who are not willing to give consent for the study.
2)Patients who will not be able to carry out yoga and exercise protocol safely, recent fall or > 3 falls in a year, recent hospitalization in 1 month, and those who fail to give consent will be excluded.
3)The patients with severe cardio-pulmonary disease, coronary artery disease, cardiomyopathy, severe musculoskeletal disease, neuropsychiatric disease, history of cardiovascular accident, active malignancy, hepatocellular carcinoma and, the end-stage renal disease.
4)Patients with decompensated cirrhosis or post liver transplant patients
5)Pregnant, lactating women
6)Patients having prior study enrolment or enrolment in another conflicting study within past 3 months.
7)Patients taking weight loss drugs or oral antidiabetic medications (GLP-1 analogues and glitazones) or any pharmacotherapy for NASH (Vitamin E and Saroglitazar).
8)Any patient not meeting any part of the inclusion criteria
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effectiveness of yoga in improving the hepatic steatosis in patients with MASLD in comparison to standard of care  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Effectiveness of yoga in decreasing the body weight, BMI, central obesity in patients with MASLD in comparison to standard of care.  6 months 
Effectiveness of yoga in improving liver variables (inflammation, fibrosis) and metabolic variables (dyslipidemia, hyperglycemia, insulin resistance) in patients with MASLD in comparison to standard of care.  6 months 
Effectiveness of yoga in improving the sarcopenic obesity and frailty in patients with MASLD in comparison to standard of care.  6 months 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="110" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   04/01/2024 
Date of Study Completion (India) 31/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 Body weight reduction by lifestyle interventions including physical exercise and dietary calorie restriction is the mainstay for the management of MASLD. Recently there has been much interest about Yoga as a lifestyle intervention in controlling bodyweight and improving liver steatosis. However the evidence is limited. The study is open - label, Non inferiority, randomised controlled trial to compare the efficacy of Yoga with dietary calorie restriction versus Exercise with dietary calorie restriction at the end of 6 months in 100 patients with MASLD. The study will be conducted at single institute - PGIMER, Chandigarh. The primary outcome will be to compare improvement in hepatic steatosis in patients doing Yoga to those doing exercise. As secondary outcome, the amount of body weight reduced, reduction in BMI, improvement in central obesity, improvement in lipid profile, insulin resistance and improvement in sarcopenia and frailty will be compared in both the groups. 
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