Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
A randomised controlled placebo based trial to determine the efficacy of a prophylactic dose of hydrocortisone and anti histamine in preventing reactions to anti snake venom
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Anaphylactoid and pryogenic reactions to anti snake venom
Intervention
Either a placebo or 100 mg of hydrocortisone and 10 mg of H1 anti histamine will be administered once reqirement for ASV has been established. All outcomes will be monitored. In the event of an adverse reaction normal treatment protocols will apply.
Intervention type
Drug
Phase
Not Specified
Drug names
Hydrocortisone and anti histamine
Primary outcome measures
Number of anaphyalactoid and pyrogenic reactions
Secondary outcome measures
Severity of reaction
Overall trial start date
01/10/2005
Overall trial end date
01/10/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Snakebite with systemic symptoms
2. Requirment for ASV
3. Have given consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
250
Participant exclusion criteria
History of severe atopic diseases
Recruitment start date
01/10/2005
Recruitment end date
01/10/2008
Locations
Countries of recruitment
India
Trial participating centre
St John's Medical College
Bangalore
560034
India
Funders
Funder type
University/education
Funder name
St John's Medical College (India)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary