Misoprostol for NASH

Misoprostol for Non-alcoholic Steatohepatitis- a Randomized Control Trial

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

Study Overview

• Status: Completed
• Conditions: NASH
• Intervention / Treatment: Drug: Misoprostol; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75600
      • Dr. Ziauddin Hospital Clifton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ziauddin University
• Collaborators: Nabiqasim Industries (Pvt) Ltd
• Investigators: Principal Investigator: Mehreen Siyal, MBBS, FCPS-1, Dr. Ziauddin Hospital Clifton

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: March 26, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: March 26, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: 3280221MSGE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No