Misoprostol for NASH

• Status: Completed
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this randomised control trial is to evaluate the effect of Misoprostol in treating patients with NASH.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ziauddin University
• Collaborator: Nabiqasim Industries (Pvt) Ltd
• Treatments: Misoprostol

Criteria

Inclusion Criteria:

1. Patients between age 25 and 64 years

2. Patients having NAFLD as evident by a radiologic test like ultrasound/fibroscan/CT scan etc.

3. ALT level of 1.5 times ULN

4. If already known case of NAFLD, then patient should be on stable doses of Vitamin E, oral hypoglycemics or anti-lipidemic drugs, with no change in medication during 6 months prior to recruitment.

Exclusion Criteria:

1. Patients with age less than 18 yrs or more than 80 yrs,

2. Women of childbearing age

3. Clinically significant acute or chronic liver disease unrelated to NAFLD

4. Evidence of hepatitis B and C

5. Evidence of primary biliary cirrhosis, primary sclerosing cholangitis, or biliary obstruction

6. Autoimmune hepatitis

7. Drug-induced steatohepatitis (ingestion of drugs known to produce hepatic steatosis including corticosteroids, high-dose estrogens, methotrexate, tetracycline or amiodarone in the previous 6 months)

8. Any cardiovascular event or evidence of active CVS disease

9. Type 1 Diabetes

10. Those consuming alcohol of over 20 grams/day for males and 10 grams/day for females

11. Severe end-organ damage

12. Human immunodeficiency virus (HIV) infection

13. Compensated and decompensated cirrhosis

14. Patients with uncontrolled diabetes

15. Mental instability or incompetence