Home » Trials » SLCTR/2015/019
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.
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SLCTR Registration Number
SLCTR/2015/019
Date of Registration
The date of last modification
Apr 30, 2019
Scientific Title of Trial
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.
Public Title of Trial
Effects of thebu leaves on fatty liver - phase 2 clinical trial
Disease or Health Condition(s) Studied
Non-alcoholic fatty liver disease
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
ERC Ruhuna Ref: 02/07/2015: 3.1
What is the research question being addressed?
What is the human efficacy and safety of a newly formulated capsule containing Costus speciosus (thebu) leaf extract on liver enzymes and insulin resistance in patients with Non-alcoholic fatty liver disease (NAFLD)?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 2
Intervention(s) planned
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.
Consenting participants meeting inclusion/exclusion criteria will be allocated into two arms using block randomization. The two arms will be randomly selected to receive either the intervention or the control. All participants will be exposed to a special dietary management plan by a dietitian.
The intervention arm will receive 250mg of Costus speciosus (thebu) leaf extract in a capsule form, twice a day for three months
The control arm will receive a matching placebo for the same frequency and duration.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
1.
|
[ At baseline, then every 4 weeks for a total of 12 weeks. ] |
Secondary outcome(s)
1.
|
[ At baseline, then every 4 weeks for a total of 12 weeks. ] |
Target number/sample size
64 (32 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2015-10-01
Anticipated end date
2016-01-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2015-07-22
Approval number
02/07/2015: 3.1
Details of Ethics Review Committee
Name: | Ethics Review Committee, Faculty of Medicine, University of Ruhuna |
Institutional Address: | PO Box 70, Labuduwa Rd, Galle, Sri Lanka |
Telephone: | +94-91-2234801/803 (Extension: 161) |
Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Prof Menik Hettihewa
Professor of Pharmacology
Department of Pharmacology
Faculty of Medicine
University of Ruhuna
Galle
Sri Lanka
0094 91 2234801 or 0094 91 22248677
0094 718051252
0094 91 2222314
hettihewamenik@gmail.com
www.med.ruh.ac.lk
Contact Person for Public Queries
Prof Menik Hettihewa
Professor of Pharmacology
Department of Pharmacology
Faculty of Medicine
University of Ruhuna
Galle
Sri Lanka
0094 91 2234801 or 0094 91 22248677
0094 718051252
0094 91 2222314
hettihewamenik@gmail.com
www.med.ruh.ac.lk
Primary study sponsor/organization
Faculty of Medicine
University of Ruhuna
PO box 70,
Karapitiya, Galle, Sri Lanka
Tel: 0094 91 2234801
www.med.ruh.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results