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ISRCTN
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ISRCTN29425449
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ClinicalTrials.gov identifier
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Public title
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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 (ASV)
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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India
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Disease/condition/study domain
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Anaphylactoid and pryogenic reactions to anti snake venom
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Participants - inclusion criteria
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1. Snakebite with systemic symptoms
2. Requirment for ASV
3. Have given consent
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Participants - exclusion criteria
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History of severe atopic diseases
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Anticipated start date
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01/10/2005
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Anticipated end date
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01/10/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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250
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Interventions
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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.
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Primary outcome measure(s)
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Number of anaphyalactoid and pyrogenic reactions
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Secondary outcome measure(s)
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Severity of reaction
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Sources of funding
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St John's Medical College (India)
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Trial website
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Publications
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Contact name
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Prof
Mabel
Vasnaik
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Address
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St John's Medical College
Johnagar
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City/town
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Bangalore
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Zip/Postcode
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560034
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Country
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India
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Sponsor
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St John's Medical College (India)
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Address
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Johnagar
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City/town
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Bangalore
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Zip/Postcode
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560034
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Country
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India
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Date applied
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19/09/2005
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Last edited
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15/09/2009
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Date ISRCTN assigned
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29/09/2005
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