Home » Trials » SLCTR/2011/012
Reducing local and systemic envenoming in hump-nosed viper bite by treating early with oral prednisolone: randomised, double blind trial in Sri Lanka
-
SLCTR Registration Number
SLCTR/2011/012
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Reducing local and systemic envenoming in hump-nosed viper bite by treating early with oral prednisolone: randomised, double blind trial in Sri Lanka
Public Title of Trial
Treatment benefit of prednisolone in hump-nosed viper bite in Sri Lanka
Disease or Health Condition(s) Studied
Hump- nosed viper envenoming
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
2011/EC/20 (Ethical review committee, Faculty of Medicine, Peradeniya)
What is the research question being addressed?
To investigate the efficacy of oral prednisolone in reducing local and systemic envenoming in hump-nosed pit viper bites ?
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
Treatment arms Group A Oral prednisolone 40 mg daily for 2 days Group B Nil
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
Primary outcome(s)
|
1.
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 |
[ Twice daily until discharge from the hospital ] |
Secondary outcome(s)
|
1.
Severity of systemic envenoming, including 1. Length of hospital stay due to systemic envenoming 2. Incidence of complications (ARF, DIC, coagulopathy) 3. Death |
[ Twice daily until discharge from the hospital ] |
Target number/sample size
Interim analysis will be done once 50 patients are randomised and these results will be used to calculate final sample size
Countries of recruitment
Sri Lanka
Anticipated start date
2011-11-30
Anticipated end date
2012-11-15
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2011-03-30
Approval number
2011/EC/20
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Peradeniya |
| Institutional Address: | Galaha Road, Kandy, Sri Lanka |
| Telephone: | +94-812396361 |
| Email: | chairpersonierc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Prof. SAM Kularatne
Department of Medicine, Faculty of Medicine, University of Peradeniya
081 2388369
0773420771
samkul@sltnet.lk
Contact Person for Public Queries
Dr. Wasantha P Dissanayaka
Consultant physician
General Hospital, Kurunegala
0777884824
wdissana@yahoo.com
Primary study sponsor/organization
Prof. SAM Kularatne
Department of Medicine, Faculty of Medicine, University of Peradeniya
0773420771
samkul@sltnet.lk
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
