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

19 Jun 2017

The date of last modification

Jan 29, 2019



Application Summary


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


Trial Details


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


Control

Placebo


Assignment

Parallel


Purpose

Treatment


Study Phase

Not Applicable


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 on ultrasonography of the hepatobilliary system


Exclusion criteria

  1. Co-infection with Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV)
  2. History of significant alcoholism


Primary outcome(s)

  1. Degree of hepatic fibrosis as determined by
    1.1. AST to Platelet Ratio Index
    1.2. Fibroscan of liver

    [

    Six months from commencing the treatment

    ]

Secondary outcome(s)

  1. None

    [

    None

    ]

Target number/sample size

200 (50 in each arm)


Countries of recruitment

Bangladesh


Anticipated start date

2017-06-25


Anticipated end date

2018-06-30


Date of first enrollment

2017-07-01


Date of study completion


Recruitment status

Recruiting


Funding source

Bangabandhu Sheikh Mujib Medical University


Regulatory approvals

Not applicable



State of Ethics Review Approval


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 & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. Md. Ayub Al Mamun
Associate Professor
Department of Hepatology Bangabandhu Sheikh Mujib Medical University Shahbag, Dhaka-1000 Bangladesh

Mob: +8801712091867

ayubmamunal@gmail.com

Contact Person for Public Queries

Dr. Sonjoy Dey
Resident
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

Secondary study sponsor (If any)

None





Trial Completion details


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