Home » Trials » SLCTR/2024/011
Anti-fibrotic effects of Silymarin among the patients of Nonalcoholic Fatty Liver Disease, a randomized control trial
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SLCTR Registration Number
SLCTR/2024/011
Date of Registration
The date of last modification
Mar 20, 2024
Scientific Title of Trial
Anti-fibrotic effects of Silymarin among the patients of Nonalcoholic Fatty Liver Disease, a randomized control trial
Public Title of Trial
Effectivity of Silymarin in improving hepatic fibrosis among patients with non alcoholic fatty liver disease – placebo controlled RCT
Disease or Health Condition(s) Studied
Nonalcoholic Fatty Liver Disease
Scientific Acronym
None
Public Acronym
None
Brief title
Effects of Silymarin in Nonalcoholic Fatty Liver Disease
Universal Trial Number
U1111-1304-8539
Any other number(s) assigned to the trial and issuing authority
59.27.0000.013.19.PG.2023.009/290 - Ethical Review Committee - Chittagong Medical College
What is the research question being addressed?
Can Silymarin improve hepatic fibrosis among the patients of Nonalcoholic Fatty Liver Disease compared to a placebo?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Participants, Outcome assessors
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 2
Intervention(s) planned
Place of study: Medicine Out Patient Department, Chittagong Medical College Hospital, Chittagong, Bangladesh
Patients who meet up inclusion and exclusions criteria will be informed in details about the study. Such 80 patients will be finally included in the study. Written informed consent in Bengali for inclusion in the trial will be obtained from all study subjects. The potential risks and benefits of the use of the drug will be explained to them.
All patients who have given consent will do baseline SGPT (ALT), SGOT(AST) and Fibroscan of Liver Consenting Patients will be divided into 2 groups using simple randomization.
Interventional product: Cap Silybin 140mg (each capsule contains Silymarin 140mg, which is the dried extract of Milk Thistle Fruit).
Group 1: Cap placebo (Capsule visually identical to Cap Silybin 140mg containing an inert substance), One(1) Capsule to be taken orally, twice(2) daily for one(1) year.
Group 2: Cap Silybin 140mg, One(1) Capsule to be taken orally, twice(2) daily for one(1) year.
All patients will get appropriate diet and lifestyle modification advice.
All patients will get appropriate treatment for comorbid diseases such as HTN, IHD, DM, Dyslipidemia or Hypothyroidism if any one or more are present, according to standard guidelines and protocols.
Inclusion criteria
Fatty liver on ultrasonography of the hepatobilliary system -
Hepatocellular steatosis is the hallmark of NAFLD, and steatosis in more than 5% of hepatocytes is required for the diagnosis of NAFLD. Fatty liver is diagnosed based on the following ultrasound parameters; parenchymal brightness, increased echogenicity of the liver parenchyma in comparison to the cortex of the right kidney, deep beam attenuation, bright vessel walls, and gallbladder wall definition.
Exclusion criteria
Primary outcome(s)
|
1.
Decrease in Fibroscan score of Liver (Kpa) |
[ After 1(one) year of treatment ] |
|
2.
Decrease in SGOT (IU/L) |
[ After 1(one) year of treatment ] |
Secondary outcome(s)
|
1.
SGOT/SGPT ratio |
[ After 1(one) year of treatment ] |
Target number/sample size
80 (40 in each arm)
Countries of recruitment
Bangladesh
Anticipated start date
2024-04-01
Anticipated end date
2024-03-17
Date of first enrollment
Date of study completion
2024-06-30
Recruitment status
Pending
Funding source
Integrated Health Science Research And Development Fund (Health Education and Family Welfare division, Ministry of Health And Family Welfare), Bang
Regulatory approvals
Ethical Review Committee, Chittagong Medical College, Chattogram,4000, Bangladesh
Status
Approved
Date of Approval
2023-09-19
Approval number
59.27.0000.013.19.PG.2023.009/290
Details of Ethics Review Committee
| Name: | Ethical Review Committee |
| Institutional Address: | Chittagong Medical College, Chattogram, 4000 Bangladesh |
| Telephone: | +88031630180 |
| Email: | cmc@ac.dghs.gov.bd |
Contact person for Scientific Queries/Principal Investigator
Dr. Sonjoy Dey
Medical Officer
Room No 212
New Building
Chittagong Medical College Hospital
Chittagong, 4000
Bangladesh
+8801725876589
ayubmamunal@gmail.com
Contact Person for Public Queries
Prof. Dr. Md. Ayub Al Mamun
Chairman
Department of Hepatology
Bangabandhu Sheikh Mujib Medical University
Shahbag, Dhaka-1000
Bangladesh
+88-031-212155
sonjoydey_cmc@yahoo.com
Primary study sponsor/organization
Integrated Health Science Research and Development Fund
Health Education and Family Welfare Division, Ministry of Health and Family Welfare, BANGLADESH
Ministry of Health and Family Welfare
Building no. 2(3rd floor)
Bangladesh Secretariat
Dhaka, 1000
Bangladesh
+8802716020
+88029559216
minister@bdcom.com
www.mohfw.gov.bd
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
2024-06-30
Final sample size
Date of first publication
Link to results
Brief summary of results
