Effect of yoga on non-alcoholic fatty liver disease (NAFLD).

Phase 3

• Conditions: Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified

• Registration Number: CTRI/2023/12/060657
• Lead Sponsor: CCRYN- COLLABORATIVE CENTRE FOR MIND BODY INTERVENTION THROUGH YOGA #3012, Research block-B,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

oNAFLD patients will be defined by the evidence of hepatic steatosis by Fibroscan with controlled attenuation parameter (CAP) >248 dB/m in the absence of significant alcohol intake ( >20 g/day irrespective of gender) or other concomitant etiologies of liver disease

oAll patients must be on stable doses of medical therapy for 6 weeks before the study start date.

oBe willing and able to participate in the full program

oBe willing and able to functionally participate in all activities set as part of the intervention

oBe able to complete all day-to-day activities and instrumental activities of daily living independently, completely without assistance from others

oAge eighteen years to sixty years

Exclusion Criteria

oPatients with cirrhosis (LSM >13.6 kPa)

oAny patient on drugs causing change in steatosis including SGLT2 inhibitors,GLP1 agonists, Vitamin E, Saroglitazar, and thiazolidinediones

oPregnant, lactating women

oPatients 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

oSignificant alcoholic consumption ( >20 g/day irrespective of gender)

oCompeting etiology for hepatic steatosis like Hep C, Medications, parenteral nutrition, Wilson’s disease and severe malnutrition

oCoexisting causes for chronic liver disease (CLD) including hemochromatosis, autoimmune liver disease, chronic viral hepatitis, Wilsons Disease and drug induced liver injury

oThe patients with severe cardio-pulmonary disease, coronary artery disease, cardiomyopathy, severe musculoskeletal disease, neuropsychiatric disease, and history of cardiovascular accident.

oAny patient not meeting any part of the inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in CAP at 6 monthsTimepoint: baseline and after 6 months

Secondary Outcome Measures

Name	Time	Method
b.Change in body weight at 6 months <br/ ><br>c.Change in waist circumference at 6-months <br/ ><br>d.Change in blood pressure at 6 months <br/ ><br>e.Change in Liver functions, Lipid profile, HbA1C at 6 months <br/ ><br>f.Change in insulin resistance (as assessed by HOMA-IR) at 6 months <br/ ><br>g.Change in hepatic inflammation (as assessed by ALT and FAST scores) and fibrosis (as assessed by APRI, FIB-4, NFS and LSM) by at 6 months <br/ ><br>h.Change in serum cytokines/adipocytokines (CRP, IL-6, TNF alpha, leptin, adiponectin) <br/ ><br>i.Change in quality of life at 6 months <br/ ><br>Timepoint: baseline and after 6 months