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Effect of Ayurvedic Formulation in the management of Metabolic Dysfucntion-Associated Steatotic Liver Disease

Evaluate the Efficacy of Ayurvedic Formulation in the management of Metabolic Dysfucntion-Associated Steatotic Liver Disease (MASLD): A Double-Blind Randomized Placebo-Controlled Proof-of-Concept Trial - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110194
Enrollment
48
Registered
2026-05-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

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

Interventions

None listed

Sponsors

Patanjali Research Foundation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Established case of Grade I and Grade II fatty liver as proven by USG.

Exclusion criteria

Exclusion criteria: Alcohol-associated liver disease (ALD) engage in heavy drinking about 4 or more drinks per day or 8 or more drinks per week for women and 5 or more drinks per day or 15 or more drinks per week for men and other causes of liver disease Inability to attend follow-up session. Pregnant, lactating women or pregnancy anticipated during study. Thyroid disease not controlled by medication Uncontrolled Hypertension Patient on Anti-tubercular therapy Patients with complications of Metabolic syndrome like Cerebrovascular Accident Myocardial Infarction Chronic Kidney disease. Patient not willing to give written informed consent.

Design outcomes

Primary

MeasureTime frame
Change in Fibro scan-determined MASLD (Grade I II)Timepoint: Baseline (Day 1) to Day 90 and Day 180

Secondary

MeasureTime frame
Change in serum levels of LFT, Lipid profile, KFT, ECG, Urine Analysis, Haemogram, Body weight, Insulin resistanceTimepoint: Baseline (Day 1) to Day 90 and Day 180;Changes in the Chronic Liver Disease Questionnaire for NAFLD NASHTimepoint: Baseline (Day 1) to Day 90 and Day 180

Countries

India

Contacts

Public ContactDr Puneet Dhamija

All India Insititute of Medical Sciences

puneet.phar@aiimsrishikesh.edu.in8475000292

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026