Home » Trials » SLCTR/2007/001
Prospective randomised controlled trial on the efficacy of propranolol on the progression of small varices /no varices in patients with cirrhosis of the liver. Treatment with propranolol versus no treatment
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SLCTR Registration Number
SLCTR/2007/001
Date of Registration
The date of last modification
Mar 03, 2019
View original TRDS
Trial Status
Scientific Title of Trial
Prospective randomised controlled trial on the efficacy of propranolol on the progression of small varices /no varices in patients with cirrhosis of the liver. Treatment with propranolol versus no treatment
Public Title of Trial
Trial on the efficacy of propranolol on the progression of varices in patients with cirrhosis
Disease or Health Condition(s) Studied
Oesophageal varices
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Does propranolol prevent the formation of varices ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
Treatment with propranolol
Inclusion criteria
Patients with clinical, biochemical, radiological features of cirrhosis confirmed wherever possible by histology 18 -70 years of age Patients with no varices or small varices (less than 5mm) No history of upper GI bleeding Patients not on any vasoactive medications
Exclusion criteria
•Patients who do not fulfill inclusion criteria •Patients currently on primary prophylaxis •Patients with severe obesity •Patients with oesophageal varices more than 5mm •Patients with gastric varices •Patients with contraindications for beta blockers •Patients with hepatocellular carcinoma •Patients with portal vein thrombosis
Primary outcome(s)
|
1.
Enlargemert of varices beyond 5mm Bleeding from oesophageal varices |
[ 2 years ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
210
Countries of recruitment
Sri Lanka
Anticipated start date
2003-01-01
Anticipated end date
2008-12-31
Date of first enrollment
2003-05-21
Date of study completion
Recruitment status
Terminated
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
Approval number
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr Anuradha Dassanayake
Senior Lecturer
Department of Pharmacology,
Faculty of Medicine, University of Kelaniya
PO Box 6, Talagolla Road, Ragama.
+94 112961157
+94 112956188
anuradhadassanayake@hotmail.com
Contact Person for Public Queries
Dr Anuradha Dassanayake
Senior Lecturer
Department of Pharmacology,
Faculty of Medicine, University of Kelaniya
PO Box 6, Talagolla Road, Ragama.
+94 112961157
+94 112956188
anuradhadassanayake@hotmail.com
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
