Effects of thebu leaves on fatty liver - phase 2 clinical trial
Phase 2
- Conditions
- on-alcoholic fatty liver disease
- Registration Number
- SLCTR/2015/019
- Lead Sponsor
- Faculty of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
1. Male and female patients aged 30-65 years
2. Diagnosis of NAFLD stage 1 and 2 by ultrasound scan by a physician and radiologist
Exclusion Criteria
1. Alcoholism.(consumption of any alcohol within the past 6 weeks)
2. Current treatment with hepatotoxic drugs.
3. Hepatitis B infection (positive HBsAg with recent vaccination)
4. Diabetes mellitus, heart failure, ischaemic heart disease
5. Autoimmune disorders.
6. Any type of long term drug treatment for diabetes, dyslipidemia or high blood pressure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. 30% reduction in insulin resistence (IR) calculated by using HOMA QUICKI and McAuley indices <br><br>2. Sustained reduction in Alanine aminotransferase(ALT) defined as 50% or less of the baseline level or 40U/L or less at clinic visits every 4 weeks.<br><br> [At baseline, then every 4 weeks for a total of 12 weeks.<br>]<br>
- Secondary Outcome Measures
Name Time Method 1. Grading of NAFLD on ultra sound scan<br>2. Health related quality of life.(QOL)<br>3. Anthropometric variables<br><br> [At baseline, then every 4 weeks for a total of 12 weeks.]<br>