Misoprostol for NASH

Study Overview
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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.

Official Title
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Misoprostol for Non-alcoholic Steatohepatitis- a Randomized Control Trial

Conditions
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NASH

Intervention / Treatment
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* Drug: Misoprostol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between age 25 and 64 years Patients having NAFLD as evident by a radiologic test like ultrasound/fibroscan/CT scan etc. ALT level of 1.5 times ULN 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: Patients with age less than 18 yrs or more than 80 yrs, Women of childbearing age Clinically significant acute or chronic liver disease unrelated to NAFLD Evidence of hepatitis B and C Evidence of primary biliary cirrhosis, primary sclerosing cholangitis, or biliary obstruction Autoimmune hepatitis 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) Any cardiovascular event or evidence of active CVS disease Type 1 Diabetes Those consuming alcohol of over 20 grams/day for males and 10 grams/day for females Severe end-organ damage Human immunodeficiency virus (HIV) infection Compensated and decompensated cirrhosis Patients with uncontrolled diabetes Mental instability or incompetence

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a double blind randomised control trial to see the effect of Misoprostol in treating patients with NASH
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Misoprostol<br>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 | Drug: Misoprostol<br>* Misoprostol is a prostaglandin E1 analogue<br>|
| Placebo Comparator: Placebo<br>Placebo was given to the patients three times daily for a duration of two months | Drug: Placebo<br>* Placebo contained substance that has no therapeutic value.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in liver function tests | The change in serum alanine aminotransferase (ALT) measured in international units per liter (IU/L), aspartate aminotransferase (AST) in IU/L, gamma-glutamyl transferase (GGT) in IU/L, alkaline phosphatase (ALP) in IU/L, total bilirubin in milligrams per decilitre (mg/dl), direct bilirubin in mg/dl and indirect bilirubin in mg/dl from baseline was ascertained by performing paired sample t-test. | Baseline to 2 Months | 
| Change From Baseline in Interleukin-6 (IL-6) | The change in Interleukin-6 measured in picograms per milliliter (pg/ml) from baseline was ascertained by performing paired sample t-test. | Baseline to 2 Months | 
| Change From Baseline in endotoxin levels | The change in endotoxin levels measured in endotoxin units per milliliter (EU/mL) from baseline was ascertained by performing paired sample t-test. | Baseline to 2 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in hepatic steatosis | The change in hepatic fibrosis from baseline, measured in kilopascals (kPa) by doing fibroscan, was ascertained by performing paired sample t-test. | Baseline to 2 Months | 
| Change From Baseline in hepatic fibrosis | The change in hepatic fibrosis from baseline, measured through the controlled attenuation parameter (CAP) by doing fibroscan, was ascertained by performing paired sample t-test. | Baseline to 2 Months | 
| Change From Baseline in dyslipidemia | The change in serum cholesterol level measured in mg/dl, triglycerides in mg/dl, HDL (high-density lipoprotein) cholesterol in mg/dl, LDL (low-density lipoprotein) cholesterol in mg/dl, VLDL (very low-density lipoprotein) cholesterol in mg/dl, non-HDL cholesterol in mg/dl, from baseline by doing fasting lipid profile and performing paired sample t-test. | Baseline to 2 Months | 
| Change From Baseline in Insulin resistance | The change in Insulin resistance as ascertained by measuring fasting insulin in millionths of an International Unit per milliliter(uU/mL), and fasting blood sugar in mg/dl and then calculating homeostasis model assessment-estimated insulin resistance (HOMA-IR). HOMA IR calculation formula: HOMA IR = fasting insulin (uU/mL) x fasting glucose (mg/dl)/405 | Baseline to 2 Months | 
| Incidence of Adverse Events | Safety and tolerability were measured by providing adverse event form to the study participants. Any adverse event experienced by the study participants was mentioned in the adverse event form and notified to the primary investigator through a phone call. | Baseline to 2 Months |