Condition category
Injury, Occupational Diseases, Poisoning
Date applied
19/09/2005
Date assigned
29/09/2005
Last edited
15/09/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Mabel Vasnaik

ORCID ID

Contact details

St John's Medical College
Johnagar
Bangalore
560034
India

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

Sponsor information

Organisation

St John's Medical College (India)

Sponsor details

Johnagar
Bangalore
560034
India

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes