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 |
| Protocol serial number | N/A |
| Sponsor | St John's Medical College (India) |
| Funder | St John's Medical College (India) |
- 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
Scientific
St John's Medical College
Johnagar
Bangalore
560034
India
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Hydrocortisone and anti histamine |
| Primary outcome measure(s) |
Number of anaphyalactoid and pyrogenic reactions |
| Key secondary outcome measure(s) |
Severity of reaction |
| Completion date | 01/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 250 |
| Key inclusion criteria | 1. Snakebite with systemic symptoms 2. Requirment for ASV 3. Have given consent |
| Key exclusion criteria | History of severe atopic diseases |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 01/10/2008 |
Locations
Countries of recruitment
- India
Study participating centre
St John's Medical College
Bangalore
560034
India
560034
India
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
