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Completed

NCT Number: NCT05804305

Misoprostol for NASH

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

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Key information

Conditions

NASH

Age range

25 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dr. Ziauddin Hospital Clifton

Karachi, Sindh, 75600, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

Misoprostol is a prostaglandin E1 analogue

Placebo

Drug

Placebo contained substance that has no therapeutic value.

Primary outcomes

  1. Change From Baseline in liver function tests

    Time frame: Baseline to 2 Months

    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.

  2. Change From Baseline in Interleukin-6 (IL-6)

    Time frame: Baseline to 2 Months

    The change in Interleukin-6 measured in picograms per milliliter (pg/ml) from baseline was ascertained by performing paired sample t-test.

  3. Change From Baseline in endotoxin levels

    Time frame: Baseline to 2 Months

    The change in endotoxin levels measured in endotoxin units per milliliter (EU/mL) from baseline was ascertained by performing paired sample t-test.

Secondary outcomes

  1. Change From Baseline in hepatic steatosis

    Time frame: Baseline to 2 Months

    The change in hepatic fibrosis from baseline, measured in kilopascals (kPa) by doing fibroscan, was ascertained by performing paired sample t-test.

  2. Change From Baseline in hepatic fibrosis

    Time frame: Baseline to 2 Months

    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.

  3. Change From Baseline in dyslipidemia

    Time frame: Baseline to 2 Months

    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.

  4. Change From Baseline in Insulin resistance

    Time frame: Baseline to 2 Months

    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

  5. Incidence of Adverse Events

    Time frame: Baseline to 2 Months

    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.

Sponsors and collaborators

Lead sponsor

Ziauddin University

Other

Collaborators

  • Nabiqasim Industries (Pvt) Ltd

Registry information

Official study title

Misoprostol for Non-alcoholic Steatohepatitis- a Randomized Control Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 7, 2023
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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