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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

23 Feb 2007

The date of last modification

Jan 30, 2019


View original TRDS


Trial Status



Application Summary


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


Trial Details


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



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization

Faculty of Medicine, University of Kelaniya

Faculty of Medicine, University of Kelaniya, PO Box 6, Talagolla Road, Ragama.



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