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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2016/013

Enrollment

Unknown

Registered

2016-06-08

Start date

2016-06-20

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonalcoholic steatohepatitis (NASH)

Interventions

The study will be carried out at the Department of Hepatology Bangabandhu Sheikh Mujib Medical University. Consenting participants meeting the inclusion/exclusion criteria will be randomized into 2

Eligibility

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Histological activity and fibrosis of the liver on liver biopsy [At baseline and the end of 12 months from initiation of the intervention]	—

Secondary

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

Measure

Time frame

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

—

Countries

Bangladesh

Contacts

Public ContactDr Mushfiqul Abrar

Resident Phase B, MD (Hepatology) course

Email: mushfiq.bsmmu.r4@gmail.comTel: +880-2-9662198.

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026