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Efficacy of Virechana followed by Gomutra-haritaki in the fatty liver disease?

AN OPEN-LABEL RANDOMIZED CONTROL TRIAL TO COMPARE THE EFFICACY OF VIRECHANA & GOMUTRA-HARITAKI VERSUS URSODEOXYCHOLIC ACID (UDCA) ON NAFLD FIBROSIS SCORE AMONG NAFLD PATIENTS

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/038277
Enrollment
68
Registered
2021-11-26
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K77- Liver disorders in diseases classified elsewhere

Interventions

None listed

Sponsors

NAD
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • NAFLD confirmed by NFS score with or without having symptoms like fatigue, mild discomfort in the upper quadrant of abdomen etc. • NAFLD patients who are refractive to standard drugs of treatment. • Willing and able to participate in study and given written informed consent. • Yogya for Virechana

Exclusion criteria

Exclusion criteria: • Excessive use of alcohol within 2 years prior to initial screening. Or alcohol intake more than 20g per day for female and less than 30 g per day for males • Uncontrolled systemic disease or medically unstable and major psychological disorders • Any dysfunction of liver besides non-alcoholic fatty liver disease like viral hepatitis liver parenchymal disease, ascites, portal hypertension, Hepato-cellular carcinoma, Auto- immune hepatitis, Primary biliary cirrhosis, Wilsons disease, and liver transplantation or any other conditions interfering with the result of the treatment Alcoholic fatty liver disease patient • Pregnant/lactating female • Virechana ayogya

Design outcomes

Primary

MeasureTime frame
1.Improvement in NAFLD Fibrosis score (Age, Hyperglycaemia, BMI, platelet Count, Albumin, aspartate aminotransferase (AST) /Serum alanine aminotransferase (ALT) ratio) along with changes in clinical presentations (relief of the following symptoms like Fatigue, indigestion, epigastric discomfort, pain abdomen, diarrhea, constipation,)Timepoint: at baseline, 60th day and 120th day.

Secondary

MeasureTime frame
1. Overall improvement in quality of life 2. USG ChangesTimepoint: 1- at baseline and 30th day, 60th day, 90th day and 120th day 2. baseline, 60 days, 120 days

Countries

India

Contacts

Public ContactDr Anshul

Shri Krishna Ayush University

drashishhmehta@gmail.com08950375285

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026