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
|
|
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
|
|
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. |