Randomized clinical trial on efficacy of telmisartan compared to vitamin E on histopathological improvement in patients with nonalcoholic steatohepatitis.

Phase 4

Conditions: onalcoholic steatohepatitis (NASH)

Registration Number: SLCTR/2016/013

Lead Sponsor: Bangabandhu Sheikh Mujib Medical University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

1.Ultrasonographic evidence of fatty liver
2.NAFLD activity score (NAS) greater than or equal to 5 on liver biopsy.

Exclusion Criteria

1. Significant alcohol intake (more than 20 gm/day).
2. History of taking drugs that may cause fatty liver (i.e. tamoxifen, valproic acid, amiodarone, methotrexate)
3. History of taking drugs that have shown benefit in previous NASH pilot studies (i.e. metformin, thiazolidinediones, fibrates).
4. Chronic liver disease due to any cause (HBV, HCV, Wilson’s disease, drug induced liver injury etc.).
5. Pregnancy.
6. Co-morbid conditions such as (COPD, CKD, CCF etc.)
7. History of recent MI (within 3 months).
8. Liver failure
9. Hypothyroidism.
10. Patient who fails to give consent for paired liver biopsy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Histological activity and fibrosis of the liver on liver biopsy [At baseline and the end of 12 months from initiation of the intervention]<br>

Secondary Outcome Measures

Name	Time	Method
1. Blood pressure (BP)<br>2. Body mass index (BMI) <br>3. Complete blood count <br>4. Erythrocyte sedimentation rate (ESR)<br>5. Fasting blood glucose (FBG)<br>6. Hepatic arterial blood flow<br>7. Prothrombin time with INR<br>8. Lipid profile (TC, TG,HDL,LDL)<br>9. Insulin resistance (HOMA-IR)<br>10. Serum aspartate transaminase (AST) and alanine transaminase (ALT) <br>11. Gamma-glutamyl transferase (GGT)<br> [Outcomes 1 and 2 will be assessed at baseline, monthly for 3 months and then every 3 months for a total of 12 months.<br><br>Outcomes 3-9 will be assessed at baseline and at the end of 12 moths.<br><br>Outcomes 10 and 11 will be assessed at baseline and then every 3 months for a total of 12 months.<br>]<br>