A non randomized controlled trial on the comparison of Delta-tocotrienol and Alpha-tocopherol Effects on Non-Alcoholic Fatty Liver Disease.
- Conditions
- on-Alcoholic Fatty Liver Disease
- Registration Number
- SLCTR/2019/038
- Lead Sponsor
- ational University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- Not specified
1. Both men and women
2. Aged 20-70 years
3. Presence of fatty liver on abdominal CT scan with a liver to spleen (L/S) attenuation ratio of less than
1.1 (indicating more than 30% hepatic steatosis)
4. Fatty Liver Index (FLI) of equal to or more than 60
5. Alanine transaminase (ALT) within reference range or mildly raised i.e. not greater than 3 times the
upper limit of 42 IU/L in male and 36 IU/L in female
1. Chronic hepatitis B and C
2. Alcoholic fatty liver Disease
3. Autoimmune liver disease
4. History or clinical evidence of liver cirrhosis
5. Hemochromatosis, Wilson’s disease
6. Diabetic patients with Hemoglobin A1c (HbA1c) more than 8.5%
7. A history of cardiovascular disease, pulmonary disease & renal disease
9. Pregnant or lactating females or females planning to become pregnant during the study period
Patients on oral insulin-sensitizing agents, herbs and vitamin supplements
10.Patients under treatment with tamoxifen, methotrexate, amiodarone, diltiazem or other drugs able to
induce fatty liver
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Mean reduction in Fatty Liver Index (FLI) from baseline to week 24 and 48 [Baseline and week 24 and week 48]<br>2. Mean reduction in the measurement of Liver Fat on CT scan (indicated by an increase in the liver-to-spleen (L/S) attenuation ratio) [ Baseline and week 24 and week 48]<br>3. Mean reduction in the measurement of Fibrosis score-4 (FIB-4) [Baseline and week 24 and week 48]<br>
- Secondary Outcome Measures
Name Time Method