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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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SLCTR |
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Last refreshed on:
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27 April 2013 |
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Main ID: |
SLCTR/2011/012 |
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Date of registration:
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25/11/2011 |
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Primary sponsor: |
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Public title:
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Treatment benefit of prednisolone in hump-nosed viper bite in Sri Lanka
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Scientific title:
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Reducing local and systemic envenoming in hump-nosed viper bite by treating early with oral prednisolone: randomised, double blind trial in Sri Lanka |
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Date of first enrolment:
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30/11/2011 |
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Target sample size:
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Interim analysis will be done once 50 patients are randomised and these results will be used to calculate final sample size |
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Recruitment status: |
Pending |
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URL:
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http://www.slctr.lk/trial_details.asp?reg_id={B819591E-D52D-43CF-9B6B-2118481D523E} |
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Study type:
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Interventional |
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Study design:
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Randomised, double blind trial
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Countries of recruitment
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Sri Lanka
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Contacts
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Name:
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Prof. SAM Kularatne
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Address:
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Department of Medicine, Faculty of Medicine, University of Peradeniya
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Telephone:
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081 2388369 /0773420771 |
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Email:
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samkul@sltnet.lk |
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Affiliation:
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Name:
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Dr. Wasantha P Dissanayaka
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Address:
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General Hospital, Kurunegala
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Telephone:
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0777884824 |
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Email:
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wdissana@yahoo.com |
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Affiliation:
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Consultant Physician |
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Key inclusion & exclusion criteria
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Inclusion criteria: • Patients with proven hump-nosed pit viper bites
• Older than 12 years of age
Exclusion criteria: • Patient who has received extended course of steroids within one month or currently receiving prednisolone, hydrocortisone, antihistamine treatments.
• Evidence of bacterial infection at the bitten site
• Patients with any febrile condition or with evidence of an infection
• Chronic medical problems
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Hump- nosed viper envenoming
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Intervention(s)
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Treatment arms
Group A
Oral prednisolone 40 mg daily for 2 days
Group B
Nil
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Primary Outcome(s)
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Severity of local envenoming, including assessment of
1. Pain
2. Local swelling
3. Local discolouration
4. Requirement of surgical interventions
5. Length of hospital stay due to local envenoming
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Secondary Outcome(s)
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Severity of systemic envenoming, including
1. Length of hospital stay due to systemic envenoming
2. Incidence of complications (ARF, DIC, coagulopathy)
3. Death
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Secondary ID(s)
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Nil known
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Source(s) of Monetary Support
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None
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