Misoprostol for NASH

Ziauddin University

Status and phase: Completed; Phase 2

Conditions: NASH

Treatments: Drug: Placebo; Drug: Misoprostol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05804305

3280221MSGE

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 25 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Misoprostol

Active Comparator group

Description:

600 mcg of Misoprostol per day in three divided doses was given to the patients in the treatment group for a period of two months

Treatment:

Drug: Misoprostol

Placebo

Placebo Comparator group

Description:

Placebo was given to the patients three times daily for a duration of two months

Treatment:

Drug: Placebo