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CTRI Number  CTRI/2019/06/019909 [Registered on: 27/06/2019] Trial Registered Prospectively
Last Modified On: 22/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Yoga and fatty liver 
Scientific Title of Study   A randomised controlled trial of 6 months yogic exercises vs. regular physical activity on body composition, multiple metabolic measures in north Indian Individuals with non-alcoholic fatty liver disease and obesity 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NAVAL K VIKRAM 
Designation  Professor 
Affiliation  A.I.I.M.S., New Delhi 
Address  Room No. 8, Department of Medicine, 3rd Floor, Cross Wing, A.I.I.M.S., New Delhi

South
DELHI
110029
India 
Phone  01126593678  
Fax  01126588663  
Email  navalvikram@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  NAVAL K VIKRAM 
Designation  Professor 
Affiliation  A.I.I.M.S., New Delhi 
Address  Room No. 8, Department of Medicine, 3rd Floor, Cross Wing, A.I.I.M.S., New Delhi


DELHI
110029
India 
Phone  01126593678  
Fax  01126588663  
Email  navalvikram@gmail.com  
 
Details of Contact Person
Public Query
 
Name  NAVAL K VIKRAM 
Designation  Professor 
Affiliation  A.I.I.M.S., New Delhi 
Address  Room No. 8, Department of Medicine, 3rd Floor, Cross Wing, A.I.I.M.S., New Delhi


DELHI
110029
India 
Phone  01126593678  
Fax  01126588663  
Email  navalvikram@gmail.com  
 
Source of Monetary or Material Support  
Government of India, Ministry of Science and Technology, Department of Science and Technology, Technology Bhavan New Delhi 110016 
 
Primary Sponsor  
Name  Department of Science and Technology Govt of India 
Address  Government of India, Ministry of Science and Technology, Department of Science and Technology, Technology Bhawan, New Delhi-110016 
Type of Sponsor  Government funding agency 
 
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 Naval K Vikram  All India Institute of Medical Sciences, New Delhi  Department of Medicine, Room No 8, 3rd Floor, Cross Wing
South
DELHI 
01126593678
01126588663
navalvikram@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, A.I.I.M.S., New Delhi  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  Regular physical activity other than yoga with dietary modifications  Regular physical activity other than yoga with dietary modifications 
Intervention  Yogic exercises  Yogic exercises for 45 to 60 minutes per day for 5 days in a week 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Body Mass index (25-35 Kg/m2)
2. Diagnosed to have NAFLD on ultrasonography/fibroscan/liver biopsy
3. Intend to follow up regularly will be included in the study 
 
ExclusionCriteria 
Details  1. Known or detected case of diabetes mellitus
2. Acute infections and advanced end-organ damage
3. History of pancreatitis/ any pancreatic disease
4. Presence of other liver diseases (alcoholic liver disease, hepatitis virus infection, autoimmune hepatitis, primary biliary cirrhosis, drug-induced liver damage etc)
5. On any medication within last one month which could potentially influence insulin secretion and/or insulin sensitivity
6. Pregnancy and lactation
7. Severe end organ damage or chronic diseases: renal/ hepatic failure, any malignancy, nephrotic syndrome, malabsorption etc.
8. Contraindications for MRI scan, loss of any limb
9. On anti-obesity drugs like orlistat, liraglutide
10. Diseases restricting moderate intensity physical activity and/or yoga exercises like Joint diseases, cardiovascular diseases
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effect of yogic exercises on body composition, metabolic profile  baseline, 3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Effect of yogic exercises on liver and pancreatic fat  baseline and 6 months 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/09/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Given the high load of NAFLD in India (nearly 20-32% of the urban population), it is important to evaluate cost-effective strategies to facilitate its reversal to normal. There are no specific and effective pharmacological agents available for the treatment of NAFLD. If yogic exercise is proved to be beneficial for weight and metabolism in subjects with NAFLD, it would present as a cost-effective, simple technique and could be recommended for management of NAFLD and its consequences. Obesity is an important public disease that has serious implication on society because of associated complications.  Sedentary lifestyle is the main cause of obesity and regular physical activity is recommended as the most important therapeutic option (ACC and AHA guidelines on obesity). However, a substantial proportion of obese persons find it difficult to adhere to such recommendations. This underlines the importance of yoga as an alternative to physical activity protocols recommended in the guidelines. Besides, yoga can be practiced indoors. Thus, it can be practiced in densely populated metropolitan cities where open parks etc are not available for physical exercises like sports and running. Moreover, yoga can also be practiced in adverse weather conditions. The study will validate the replacement of yoga which can be practiced more conveniently then other forms of physical exercises/activities.

 
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