| 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 (in lay language) | Treatment benefit of prednisolone in hump-nosed viper bite in Sri Lanka | |
| Acronym, if any | None | |
| Brief title, if any | None | |
| Any
other number(s) assigned to the trial and issuing authoruty, if any (eg. sponsor, other trial registry) |
Nil known | |
| Disease or Health Condition(s) studied | Hump- nosed viper envenoming | |
| 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 ? | |
| Study design | Randomised, double blind trial | |
| 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 |
|
| 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 | |
| Primary outcome(s) | 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 |
|
| Primary outcome(s) - time of assessment(s) | Twice daily until discharge from the hospital | |
| Secondary outcome(s) | Severity of systemic envenoming, including 1. Length of hospital stay due to systemic envenoming 2. Incidence of complications (ARF, DIC, coagulopathy) 3. Death |
|
| Secondary outcome(s) - time of assessment(s) | Twice daily until discharge from the hospital | |
| Countries of recruitment | Sri Lanka | |
| Anticipated start date | 30/11/2011 | |
| Anticipated end date | 15/11/2012 | |
| Recruitment status | Pending | |
| State of ethics review approval | Ethical Review Committee, Faculty of Medicine, University of Peradeniya 2011/EC/20 | |
| Funding source(s) | None | |
| Applicant's Email | samkul@sltnet.lk | |
| Approval Status | Approved | |
| 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 |
|
| Primary Study Sponsor/ Organization | Prof. SAM Kularatne
Department of Medicine, Faculty of Medicine, University of Peradeniya 0773420771 samkul@sltnet.lk |
|
| Contact Person for Public Queries | Dr. Wasantha P Dissanayaka Consultant Physician General Hospital, Kurunegala 0777884824 wdissana@yahoo.com |
|
| Secondary Study Sponsor(s), (if any) | None |
|
