Status:
COMPLETED
AScVS and/ or Prazosin for Scorpion Envenomation
Lead Sponsor:
Haffkine Bio-Pharmaceutical Corporation Ltd.
Conditions:
Scorpion Envenomation
Eligibility:
All Genders
12-65 years
Phase:
PHASE3
Brief Summary
The data available for the efficacy of AScVS and prazosin is generated through different trials done in different clinical setting. Hence it was felt worthwhile to confirm the documented efficacy of A...
Detailed Description
Red Scorpion (Mesobuthus Tamulus Concanesis Pocock) sting is a common medical emergency in the coastal regions of India and is a cause for considerable morbidity and mortality. Signs and symptoms sho...
Eligibility Criteria
Inclusion
- (All of the following)
- Patients of both sexes, in the age range of 12-65 years
- reporting to the PHC/ hospital within 48 hours of scorpion sting and
- associated with s/s of scorpion envenomation having composite score between 5 and 21 (as computed based on the criteria below:)
- Criteria Grade Symptoms
- Sweating 0 Limited to the extremity of the sting site.
- Minimal sweating all over the body, slight nasal secretions
- Generalized sweating with rigors and cold extremities.
- Gen.profuse sweating,wetting of clothes and cold clammy skin.
- Pulse rate 0 70- 90
- 91 - 100
- 101 - 120 or \< 70
- 121 - 140 or \< 60 or irreg pulse
- 141 - 160
- \> 160
- Respiratory rate 0 \< 20
- 20 - 30
- 31 - 40 without crepitations
- 31 - 40 with crepitations
- \> 40 with crepitations
- \> 40 with crepitations and cyanosis
- Blood pressure 0 120/80
- Systolic: 121 -140 and diastolic: 81 -90
- Systolic: 141 -160 and diastolic: 91-100
- Syst: 161 -180 and diast: 101-110 Or syst \<100
- Syst: 181 -200 and diast: 111-120 Or syst \<100
- Syst: \> 200 and diast: \>120 Or syst \< 60
- CNS effects 0 No sensory involvement
- Minimal tingling numbness around mouth
- Tingling, numbness around mouth and giddiness
- Altered sensorium, patient roudy
- Patient semiconscious
- Patient unconscious
- Priapism 2 Slight erection 3 Strong erection
- To obtain a composite score, grades for individual criterion will be added. Maximum score: 25 and minimum score: 0
Exclusion
- (Any of the following)
- Composite score less than 5 and greater than 21.
- Grade of 5 in any of the criterion
- Severe Pulmonary edema with oxygen saturation below 80%.
- Severe scorpion envenomation with reporting time more than 2 days
- Any other serious medical disease which/treatment of which may confound the results e.g. cardiac diseases, diabetes, renal diseases etc.
- Severe anaphylactic reaction to any of the study drugs
- Patient (or relative in case of child) not willing to participate
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00753064
Start Date
September 1 2006
End Date
December 1 2007
Last Update
September 16 2008
Active Locations (5)
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1
Kushte Hospital
Chiplūn, Maharashtra, India, 415605
2
Natu Hospital
Chiplūn, Maharashtra, India, 415605
3
Sane Hospital
Chiplūn, Maharashtra, India, 415605
4
Mangaon cottage hospital, Mangaon.
Dist. Raigad., Maharashtra, India, 402104