| Trial ID: | L0866 |
| Source ID: | SLCTR/2015/019
|
| Associated Drug: |
Costus speciosus
|
| Title: |
Phase II clinical trial - the effects of extract of Costus speciosus (thebu) on hepatic insulin resistance and biochemical profile of patients with nonalcoholic fatty liver disease.
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic fatty liver disease
|
| Interventions: |
The study will be carried out at the Department of Pharmacology Faculty of Medicine University of Ruhuna with ultra sound scanning done at Teaching Hospital Karapitiya.<br><br>Consenting participants meeting inclusion/exclusion criteria will be allocated
|
| Outcome Measures: |
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>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>
|
| Sponsor/Collaborators: |
Faculty of Medicine
|
| Gender: |
--
|
| Age: |
nannan
|
| Phases: |
Phase 2
|
| Enrollment: |
64 (32 in each arm)
|
| Study Type: |
Interventional
|
| Study Designs: |
Randomized controlled trial
|
| Start Date: |
15/09/2015
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
7 February 2022
|
| Locations: |
Sri Lanka
|
| URL: |
https://slctr.lk/trials/slctr-2015-019
|
