| Trial ID: | L0093 |
| Source ID: | NCT03836937
|
| Associated Drug: |
Obeticholic Acid
|
| Title: |
Role of Obeticholic Acid in the Patients of NAFLD With Raised ALT
|
| Acronym: |
NAFLD
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-Alcoholic Fatty Liver Disease
|
| Interventions: |
Drug: Obeticholic acid
|
| Outcome Measures: |
Change in fibroscan score (Kpa) and CAP value (Kpa) which signifies fibrosis and steatosis status respectively.|Change in BMI (weight in kg/height in meter square)|Change in ALT (U/L)|Fasting blood sugar (FBS) (mmol/L)|2 hours after 75 gm glucose (mmol/L)|Serum bilirubin (mg/dl)|Aspertate aminotransferase (AST) (U/L)|Gamma glutamyle transpeptidase (GGT) (U/L)|Serum albumin (gm/dl)|Prothrombin time (PT) (sec)|Total cholesterol (mg/dl)|Triglyceride (TG) (mg/dl)|LDL cholesterol (mg/dl)|HDL cholesterol (mg/dl)
|
| Sponsor/Collaborators: |
Sir Salimullah Medical College Mitford Hospital
|
| Gender: |
All
|
| Age: |
18 Years to 65 Years ?? (Adult, Older Adult)
|
| Phases: |
Not applicable
|
| Enrollment: |
70
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
|
| Start Date: |
March 5, 2019
|
| Completion Date: |
December 2020
|
| Results First Posted: |
--
|
| Last Update Posted: |
November 10, 2020
|
| Locations: |
Department of Hepatology, Dhaka, Bangladesh
|
| URL: |
https://ClinicalTrials.gov/show/NCT03836937
|
