The aim of this randomised control trial is to evaluate the effect of Misoprostol in treating patients with NASH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Misoprostol is a prostaglandin E1 analogue
Placebo contained substance that has no therapeutic value.
Dr. Ziauddin Hospital Clifton
Karachi, Sindh, Pakistan
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 2 Months
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.
Time frame: 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.
Time frame: 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.
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Time frame: 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
Time frame: 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.
Time frame: Baseline to 2 Months