Effect of Ayush PTK on metabolic parameters, and hepatic steatosis/fibrosis in Metabolic dysfunction associated steatotic liver disease.

Effect of Ayush PTK on metabolic parameters, and hepatic steatosis or fibrosis in Metabolic dysfunction associated steatotic liver disease: A Randomised controlled trial. - Nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080938

Enrollment

179

Registered

2025-02-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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

Conditions

Health Condition 1: K758- Other specified inflammatory liverdiseases

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with NAFLD/MASLD with elevated liver enzymes with or without fibrosis 2. Willing to give written consent for the study

Exclusion criteria

Exclusion criteria: 1. Cirrhosis 2. Presence of other etiologies for fatty liver, eg alcohol, drugs, viral infections, autoimmune hepatitis 3. Uncontrolled diabetes 4. BMI greater than 35 5. AST or ALT greater than 5 times normal 6. Patients on Vit E, Saraglitazor, SGLT-2 7. Patients on Pioglitazone 8. Patients planned for Bariatric surgery or post-bariatric surgery 9. Planned for endoscopic interventions 10. Patients on bile acid chelators/ursodeoxycholic acid/obeticholic acid

Design outcomes

Primary

Measure	Time frame
Fraction of patients achieving greater than 30% MRI-PDFF change in each arm (responders)Timepoint: 1 year	—

Secondary

Measure	Time frame
1. Change in liver enzymes- AST and ALT 2. Changes in BMI of patients in both arms (at baseline and at end of 1 year) 3. Changes in LSM, and CAP on Fibroscan 4. Insulin resistance and lipid profile Timepoint: 1. 1 year 2. 1 year 3. 1 year 4. 1 year	—

Countries

India

Contacts

Public ContactDr Shalimar

All India Institute of medical Sciences

drshalimar@yahoo.com9868397211

Outcome results