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)

ISRCTN ISRCTN29425449
DOI https://doi.org/10.1186/ISRCTN29425449
Secondary identifying numbers N/A
Submission date
19/09/2005
Registration date
29/09/2005
Last edited
15/09/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Mabel Vasnaik
Scientific

St John's Medical College
Johnagar
Bangalore
560034
India

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific title
Study objectivesA 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAnaphylactoid and pryogenic reactions to anti snake venom
InterventionEither 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Hydrocortisone and anti histamine
Primary outcome measureNumber of anaphyalactoid and pyrogenic reactions
Secondary outcome measuresSeverity of reaction
Overall study start date01/10/2005
Completion date01/10/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants250
Key inclusion criteria1. Snakebite with systemic symptoms
2. Requirment for ASV
3. Have given consent
Key exclusion criteriaHistory of severe atopic diseases
Date of first enrolment01/10/2005
Date of final enrolment01/10/2008

Locations

Countries of recruitment

  • India

Study participating centre

St John's Medical College
Bangalore
560034
India

Sponsor information

St John's Medical College (India)
University/education

Johnagar
Bangalore
560034
India

ROR logo "ROR" https://ror.org/04z7fc725

Funders

Funder type

University/education

St John's Medical College (India)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan