AScVS and/ or Prazosin for Scorpion Envenomation

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.

Conditions

• Scorpion Envenomation

Interventions

DRUG

Antiscorpion venom serum(AScVS).

AScVS therapy group If the score is 5 and if the patient belongs to pediatric group(\>12-14): 1 vial AScVS as i.v. slow bolus after test dose If the score is 5 and if the patient is adult: 2 vials of AScVS as i.v. slow bolus after test dose. For injection, 1 vial will be dissolved in 10 ml distilled water and given over a period of 4 to 5 minutes. According to the scores 1 vial for pediatric and 2 vials for adult patient will be increased as shown below: Vials of AScVS Composite score Child Adult 5-10 2 4 \> 10-15 3 6 \>15- 21 4 8

DRUG

T.Prazosin

Prazosin therapy Prazosin (30 micrograms/Kg/dose): 500 micrograms for pediatric patient, and 1mg for adult patients) will be given every 3 hourly orally till complete recovery.

DRUG

AScVS + Prazosin

Combination AScVS and Prazosin therapy In this group, AScVS therapy will be given as mentioned in AScVS therapy group and in addition, prazosin(500 micrograms for pediatric patient and 1mg for adult patients,30 micrograms/Kg/dose) every 3 hourly will be given.

Sponsors & Collaborators

• Haffkine Bio-Pharmaceutical Corporation Ltd.

  lead INDUSTRY

Principal Investigators

• Dr Vivek S Natu, M.S. · Vijayshree Hospital, Umroli, Chiplun, Ratnagiri, Maharashtra, India.

• Dr. Santosh Kamerkar, M.S · Cottage Hospital Mangaon,Raigad,Maharashtra, India

• Dr. Geeta Kadam, M.B.B.S. · Cottage Hospital Mangaon,Raigad,Maharashtra, India

• Dr. Vidya Kamble, M.B.B.S. · Cottage Hospital Mangaon,Raigad,Maharashtra, India

• Dr. Vikas Natu, MBBS DCH · Natu Hospital Chiplun,Ratnagiri, Maharashtra,India

• Dr. Sanjeev Sane, MBBS DCH · Sane Hospital Chiplun,Ratnagiri, Maharashtra,India

• Dr. Rajesh Kushte, MBBSDCH · Kushte Hospital Chiplun,Ratnagiri, Maharashtra,India

• Dr. Sunil Thatte, M.D. · Attending physician at Natu, Sane & Kushte Hospital Chiplun,Ratnagiri, Maharashtra,India

• Dr. Uchil Dinesh, Ph.D. · A.R.C. K.E.M. Hospital Mumbai,Maharashtra,India

• Dr. Nirmala Rege, M.D. · A.R.C. K.E.M. Hospital Mumbai,Maharashtra,India

• Dr. Ravindra Bapat, M.S. · K.E.M. Hospital Mumbai,Maharashtra,India

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-09-30

Primary Completion

2007-12-31

Completion

2007-12-31

Countries

• India

Study Locations