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| Name | Class |
|---|---|
| Nabiqasim Industries (Pvt) Ltd | INDUSTRY |
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The aim of this randomised control trial is to evaluate the effect of Misoprostol in treating patients with NASH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo | Placebo Comparator | Placebo was given to the patients three times daily for a duration of two months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | Misoprostol is a prostaglandin E1 analogue |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change From Baseline in hepatic fibrosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mehreen Siyal, MBBS, FCPS-1 | Dr. Ziauddin Hospital Clifton | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Ziauddin Hospital Clifton | Karachi | Sindh | 75600 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38844374 | Derived | 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. |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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This is a double blind randomised control trial to see the effect of Misoprostol in treating patients with NASH
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Double-blind
| Placebo |
| Drug |
Placebo contained substance that has no therapeutic value. |
|
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 |
| 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 |
| 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 |
| 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 |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |