Condition category
Injury, Occupational Diseases, Poisoning
Date applied
20/09/2005
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

Dr Joseph Joseph

ORCID ID

Contact details

Little Flower Hospital and Research Centre
Kalady Road
Angamaly Kerala
683572
India

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

That subcutaneous prophylactic adrenaline reduces the number of adverse anti snake venom reactions

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 or Pyrogenic reactions to anti snake venom

Intervention

Subcutaneous Adrenaline will be administered before ASV. Control: Placebo. All outcomes will be monitored.

Intervention type

Drug

Phase

Not Specified

Drug names

Adrenaline

Primary outcome measures

Level of adverse reactions

Secondary outcome measures

Severity of reactions

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. Requirement for ASV
3. Consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

250

Participant exclusion criteria

1. Severe atopic diseases such as asthma
2. Acute cardiac conditions
3. Pregnant women and children <15 years

Recruitment start date

01/10/2005

Recruitment end date

01/10/2008

Locations

Countries of recruitment

India

Trial participating centre

Little Flower Hospital and Research Centre
Angamaly Kerala
683572
India

Sponsor information

Organisation

Little Flower Hospital and Research Centre (India)

Sponsor details

PB No. 23
Kalady Road
Angamaly Kerala
683572
India

Sponsor type

Hospital/treatment centre

Website

http://www.lfsru.org

Funders

Funder type

Hospital/treatment centre

Funder name

Little Flower Hospital (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