Comparative Study of Efficacy of Antiscorpion Venom Serum(AScVS)vs Prazosin in the Management of Severe Scorpion(Mesobuthus Tamulus Concanesis Pocock)Envenomation and Evaluation of Effects of the Combination of AScVS + Prazosin Therapy.
Sponsor study identifier
interventional
81
1 country
5
Study Start
September 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2007
Actual (reported)Study Completion
December 2007
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2007
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2006
Date type not reportedThis date has not been verified as actual or estimated.
December 2007
Actual (reported)December 2007
Actual (reported)September 14, 2008
Actual (reported)September 16, 2008
Actual (reported)Superiority of AScVS and AScVS+Prazosin was confirmed over use of Prazosin alone.
1year 4 months.
a clinical scoring system for dose requirement for AScVS is evolved based on sweating, pulse rate, respiratory rate, blood pressure, CNS effects and presence of priapism. Computed doses were given according to clinical grading as intravenous bolus slowly.
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.
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
Kushte Hospital
Chiplūn, Maharashtra, 415605, India
Natu Hospital
Chiplūn, Maharashtra, 415605, India
Sane Hospital
Chiplūn, Maharashtra, 415605, India
Mangaon cottage hospital, Mangaon.
Dist. Raigad., Maharashtra, 402104, India
Vijayshree Hospital,At & Po.Umroli,Tal. Chiplun.
Dist. Ratnagiri., Maharashtra, 415702, India
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
81 participants (actual enrollment reported by the registry).
First Submitted
September 14, 2008
First Posted
September 16, 2008
Study Start
September 2006
Date type not reportedThis date has not been verified as actual or estimated.
Clinical Severity in Scorpion Envenomation: Home Remedies, Delay to Medical Care, and Antivenom Dosing Strategies in an Emergency Department
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.
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.
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.
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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
Primary Completion
December 2007
Actual (reported)Study Completion
December 2007
Actual (reported)Last Updated
September 16, 2008
Record last verified: 2008-09
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