Misoprostol for NASH

NCT05804305 | Completed Phase 2

• 1 other identifier: 3280221MSGE
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

NASH

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Change From Baseline in hepatic steatosis

  Baseline to 2 Months

• Change From Baseline in hepatic fibrosis

  Baseline to 2 Months

• Change From Baseline in dyslipidemia

  Baseline to 2 Months

• Change From Baseline in Insulin resistance

  Baseline to 2 Months

• Incidence of Adverse Events

  Baseline to 2 Months

Study Arms (2)

Misoprostol

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Misoprostol DRUG

Misoprostol is a prostaglandin E1 analogue

Misoprostol

Placebo DRUG

Placebo contained substance that has no therapeutic value.

Placebo

Eligibility Criteria

• Age: 25 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ziauddin University: lead
• Nabiqasim Industries (Pvt) Ltd: collaborator

Study Sites (1)

Dr. Ziauddin Hospital Clifton

Karachi, Sindh, 75600, Pakistan

Location

Related Publications (1)

• Siyal M, Abbas Z, Qadeer MA, Saeed A, Ali U, Khatoon A. Misoprostol for non-alcoholic steatohepatitis: a randomised control trial. BMJ Open Gastroenterol. 2024 Jun 6;11(1):e001342. doi: 10.1136/bmjgast-2023-001342.

  PMID: 38844374 DERIVED

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Mehreen Siyal, MBBS, FCPS-1

  Dr. Ziauddin Hospital Clifton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: April 7, 2023
• Study Start: July 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 7, 2023

Record last verified: 2023-03

Locations

PA (1)