Misoprostol for NASH

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2022-12-31

Brief Summary

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

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Detailed Description

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Conditions

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NASH

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a double blind randomised control trial to see the effect of Misoprostol in treating patients with NASH

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-blind

Study Groups

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Misoprostol

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

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

Misoprostol is a prostaglandin E1 analogue

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo contained substance that has no therapeutic value.

Interventions

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Misoprostol

Misoprostol is a prostaglandin E1 analogue

Intervention Type DRUG

Placebo

Placebo contained substance that has no therapeutic value.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No