AScVS and/ or Prazosin for Scorpion Envenomation

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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 AScVS and prazosin in terms of time taken for clinical recovery in a clinical trial. Along with this, effects of both the therapies on various biochemical parameters will be recorded and compared with. It was also felt necessary to study the effect of combination on the clinical outcome.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haffkine Bio-Pharmaceutical Corporation Ltd.
• Treatments: Prazosin

Criteria

Inclusion Criteria: (All of the following)

1. Patients of both sexes, in the age range of 12-65 years

2. reporting to the PHC/ hospital within 48 hours of scorpion sting and

3. 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.

1. Minimal sweating all over the body, slight nasal secretions

2. Generalized sweating with rigors and cold extremities.

3. Gen.profuse sweating,wetting of clothes and cold clammy skin.

Pulse rate 0 70- 90

1. 91 - 100

2. 101 - 120 or < 70

3. 121 - 140 or < 60 or irreg pulse

4. 141 - 160

5. > 160

Respiratory rate 0 < 20

1. 20 - 30

2. 31 - 40 without crepitations

3. 31 - 40 with crepitations

4. > 40 with crepitations

5. > 40 with crepitations and cyanosis

Blood pressure 0 120/80

1. Systolic: 121 -140 and diastolic: 81 -90

2. Systolic: 141 -160 and diastolic: 91-100

3. Syst: 161 -180 and diast: 101-110 Or syst <100

4. Syst: 181 -200 and diast: 111-120 Or syst <100

5. Syst: > 200 and diast: >120 Or syst < 60

CNS effects 0 No sensory involvement

1. Minimal tingling numbness around mouth

2. Tingling, numbness around mouth and giddiness

3. Altered sensorium, patient roudy

4. Patient semiconscious

5. 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 Criteria: (Any of the following)

1. Composite score less than 5 and greater than 21.

2. Grade of 5 in any of the criterion

3. Severe Pulmonary edema with oxygen saturation below 80%.

4. Severe scorpion envenomation with reporting time more than 2 days

5. Any other serious medical disease which/treatment of which may confound the results e.g. cardiac diseases, diabetes, renal diseases etc.

6. Severe anaphylactic reaction to any of the study drugs

7. Patient (or relative in case of child) not willing to participate