Misoprostol for NASH

NASH Clinical Trial

Official title:

Misoprostol for Non-alcoholic Steatohepatitis- a Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05804305
• Other study ID #: 3280221MSGE
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Ziauddin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• NASH

Intervention

Drug:
• Misoprostol
Misoprostol is a prostaglandin E1 analogue
• Placebo
Placebo contained substance that has no therapeutic value.

Locations

Country	Name	City	State
Pakistan	Dr. Ziauddin Hospital Clifton	Karachi	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
Ziauddin University	Nabiqasim Industries (Pvt) Ltd

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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