Health Condition 1: K768- Other specified diseases of liver
Conditions
Interventions
Intervention1: Integrated Ayurveda, Yoga & Naturopathy: Participants in the intervention group will receive standard conventional care along with an integrative therapeutic program incorporating Ayurv
Sponsors
Patanjali Research Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1.Both male and female participants aged 18 60 years diagnosed with Non-Alcoholic Fatty Liver Disease (NAFLD) based on clinical evaluation and abdominal ultrasonography showing fatty liver (Grade 1 3). 2.Patients with mild to moderate hepatic steatosis without evidence of advanced liver disease such as cirrhosis. 3.Patients willing to participate in the integrative intervention including Ayurveda, Naturopathy, and Yogic practices and able to comply with study procedures and follow-up visits. 4.Patients who are stable on routine medical care and lifestyle advice, if any, for at least the past one month. 5.Patients who provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Patients with alcohol-related liver disease or significant alcohol consumption. 2.Patients with other chronic liver diseases such as viral hepatitis (Hepatitis B or C), autoimmune hepatitis, Wilson s disease, or drug-induced liver injury. 3.Patients with advanced liver disease, including cirrhosis, liver failure, or hepatocellular carcinoma. 4.Patients with severe systemic comorbidities such as cardiovascular disease, renal failure, or active infection that may interfere with the study outcomes. 5.Pregnant or lactating women. 6.Patients who are currently participating in another clinical trial or receiving alternative therapies that may influence liver function or metabolic parameters.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in liver function parameters, including serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels, from baseline to the end of the intervention. Change in hepatic steatosis severity, assessed by abdominal ultrasonography grading of fatty liver, from baseline to the end of the intervention.Timepoint: ALT and AST levels: Baseline (Week 0) and Endline (Week 12) Ultrasonography grading of fatty liver: Baseline (Week 0) and Endline (Week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in body weight, BMI, waist circumference, and waist hip ratio from baseline to Weeks 6 and 12. Change in fasting blood glucose and lipid profile parameters from baseline to Weeks 6 and 12. Change in insulin resistance indices from baseline to Week 12. Change in WHOQOL-BREF score from baseline to Weeks 6 and 12. Change in dietary and lifestyle assessment scores from baseline to Weeks 6 and 12. Incidence of adverse events during the 12-week study period.Timepoint: Anthropometric parameters (Body weight, BMI, Waist circumference, Waist hip ratio): Baseline (Week 0), Follow up (Week 6), and Endline (Week 12) Fasting blood glucose: Baseline (Week 0), Follow up (Week 6), and Endline (Week 12) Lipid profile (Total cholesterol, Triglycerides, HDL, LDL): Baseline (Week 0), Follow up (Week 6), and Endline (Week 12) Insulin resistance indicators: Baseline (Week 0) and Endline (Week 12) Quality of life (WHOQOL-BREF): Baseline (Week 0), Follow up (Week 6), and Endline (Week 12) Dietary habits and lifestyle patterns: Baseline (Week 0), Follow up (Week 6), and Endline (Week 12) Adverse events and safety monitoring: Continuously from enrollment until study completion (Week 12) | — |
Countries
India
Contacts
Public ContactDr Prashant Katiyar
Patanjali Research Foundation, Haridwar
Outcome results
None listed