NASH
Conditions
Brief summary
The aim of this randomised control trial is to evaluate the effect of Misoprostol in treating patients with NASH.
Interventions
DRUGMisoprostol
Misoprostol is a prostaglandin E1 analogue
DRUGPlacebo
Placebo contained substance that has no therapeutic value.
Sponsors
Nabiqasim Industries (Pvt) Ltd
Ziauddin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind
Intervention model description
This is a double blind randomised control trial to see the effect of Misoprostol in treating patients with NASH
Eligibility
Sex/Gender
ALL
Age
25 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in liver function tests | 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. |
| Change From Baseline in Interleukin-6 (IL-6) | 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. |
| Change From Baseline in endotoxin levels | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Insulin resistance | 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 |
| Change From Baseline in hepatic steatosis | 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. |
| Incidence of Adverse Events | 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. |
| Change From Baseline in hepatic fibrosis | 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. |
| Change From Baseline in dyslipidemia | 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. |
Countries
Pakistan
Outcome results
None listed