Home » Trials » SLCTR/2017/016
Efficacy of Silymarin (Milk Thistle fruit extract) compared to placebo in improving liver fibrosis in patients with non-alcoholic fatty liver disease, a Pilot Study
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SLCTR Registration Number
SLCTR/2017/016
Date of Registration
The date of last modification
Mar 19, 2024
Scientific Title of Trial
Efficacy of Silymarin (Milk Thistle fruit extract) compared to placebo in improving liver fibrosis in patients with non-alcoholic fatty liver disease, a Pilot Study
Public Title of Trial
Effects of Silymarin (Milk thistle fruit extract) on liver fibrosis in Nonalcoholic Fatty Liver Disease
Disease or Health Condition(s) Studied
Non alcoholic fatty liver disease
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1195-5772
Any other number(s) assigned to the trial and issuing authority
BSMMU/2017/1029 (IRB: Bangabandhu Sheikh Mujib Medical University
What is the research question being addressed?
What is the effect of Silymerin compared to a placebo in improving liver fibrosis in patients with non-alcoholic fatty liver disease?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used : Participants, Outcome assessors
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 2
Intervention(s) planned
The study will be carried out at the hepatology Out Patient Department of the Bangabandhu Sheikh Mujib Medical University.
Consenting patients meeting inclusion/exclusion criteria will be allocated into four study arms using simple randomization.
Interventional product: Cap SILIVER 140 (each capsule contains Silymarin 140 mg, which is the dried extract of Milk Thistle Fruit).
Arm 1: Placebo (capsules visually identical containing 140mg inert substance); one capsule to be taken orally, once daily for 6 months Arm 2: Silymarin 2 capsules (280mg) to be taken orally, once daily for 6 months Arm 3: Silymarin 3 capsules (420mg) to be taken orally, once daily for 6 months Arm 4: Silymarin 4 capsules (560mg) to be taken orally, once daily for 6 months
All participants will receive appropriate diet and lifestyle modification advice. All patients will be provided with appropriate treatment for comorbid diseases such as Hypertension (HTN), Ischemic heart disease (IHD), Diabetes Mellitus (DM), dyslipidemia or hypothyroidism according to standard guidelines and protocols.
Inclusion criteria
Fatty liver in ultrasonography of hepatobilliary system
Exclusion criteria
Primary outcome(s)
|
1.
Degree of hepatic fibrosis as determined by 1. AST to Platelet Ratio Index 2. Fibroscan of liver |
[ Six months from commencing the treatment ] |
Secondary outcome(s)
|
1.
SGOT/SGPT ratio |
[ One year ] |
Target number/sample size
80 (20 in each arm)
Countries of recruitment
Bangladesh
Anticipated start date
2024-03-15
Anticipated end date
2026-03-15
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
Bangabandhu Sheikh Mujib Medical University
Regulatory approvals
Ethical Review Committee, Chittagong Medical College, Chattogram,4000, Bangladesh
Status
Approved
Date of Approval
2017-01-30
Approval number
BSMMU/2017/1029
Details of Ethics Review Committee
| Name: | Institutional Review Board of Bangabandhu Sheikh Mujib Medical University |
| Institutional Address: | Shahbag, Dhaka, Bangladesh |
| Telephone: | +880-9661064 |
| Email: | registrar@bsmmu.edu.bd |
Contact person for Scientific Queries/Principal Investigator
Prof. Md. Ayub Al Mamun
Chairman
Department of Hepatology Bangabandhu Sheikh Mujib Medical University
Shahbag, Dhaka-1000 Bangladesh
Mob: +8801725876589
ayubmamunal@gmail.com
Contact Person for Public Queries
Dr. Sonjoy Dey
Resident Medical officer
Department of Hepatology Bangabandhu Sheikh Mujib Medical University
Shahbag, Dhaka-1000 Bangladesh
Mob: +8801712243805
sonjoydey_cmc40l@yahoo.com
Primary study sponsor/organization
Department of Hepatology Bangabandhu Sheikh Mujib Medical University
Shahbag, Dhaka-1000
Bangladesh
Tel: +88 02 55165760-94
http://www.bsmmu.edu.bd/index.php?module=dp&dp=6&trg=139028968042
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
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
