Home » Trials » SLCTR/2014/016
Effect of pentoxyfylline on histological activity and fibrosis of patients with nonalcoholic steatohepatitis
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SLCTR Registration Number
SLCTR/2014/016
Date of Registration
The date of last modification
Apr 30, 2019
Trial Status
Scientific Title of Trial
Effect of pentoxyfylline on histological activity and fibrosis of patients with nonalcoholic steatohepatitis
Public Title of Trial
Effectiveness of pentoxyfylline in patients with fatty liver
Disease or Health Condition(s) Studied
Nonalcoholic steatohepatitis
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1155-2061
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Does Pentoxyfylline improve nonalcoholic fatty liver disease activity score & fibrosis score in patients with nonalcoholic steatohepatitis?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
Consenting participants meeting inclusion/exclusion criteria will be randomized into two arms using the lottery method.
The intervention arm will receive Pentoxyfylline 400mg eight hourly for one year. Standard therapy will be provided concurrently.
The control arm will receive standard therapy alone.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Improvement of nonalcoholic fatty liver disease activity score and fibrosis score after one year treatment |
[ At the end of one year ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
30
Countries of recruitment
Bangladesh
Anticipated start date
2014-09-01
Anticipated end date
2015-12-31
Date of first enrollment
2014-09-01
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2014-01-12
Approval number
BSMMU/2014/1657
Details of Ethics Review Committee
| Name: | Institutional Review Board of Bangabandhu Sheikh Mujib Medical University |
| Institutional Address: | Shahbag,Dhaka, Bangladesh |
| Telephone: | +880-8612550 |
| Email: | bsmmu@bangala.net |
Contact person for Scientific Queries/Principal Investigator
Dr. S.K.M. Nazmul Hasan
Resident of Hepatology
Bangabandhu Sheikh Mujib Medical University, Shahbag, Dhaka -1000 ,Bangladesh
8801916045601
dr.nazmul01@gmail.com
Contact Person for Public Queries
Dr. Md.Shahinul Alam
Associate Professor of Hepatology
Bangabandhu Sheikh Mujib Medical University,
Shahbag, Dhaka-1000, Bangladesh
8801973007173
88029130473
shahinul67@yahoo.com
Primary study sponsor/organization
Bangabandhu Sheikh Mujib Medical University
Shahbag. Dhaka- 1000. Bangladesh
+88 02 9661065, +88 02 8624816
88029130473
info@bsmmu.org
www.bsmmu.edu.bd
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
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
