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Sponsored by: |
Haffkine Bio-Pharmaceutical Corporation Ltd. |
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Information provided by: | Haffkine Bio-Pharmaceutical Corporation Ltd. |
ClinicalTrials.gov Identifier: | NCT00753064 |
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.
Condition | Intervention | Phase |
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Scorpion Envenomation |
Drug: Antiscorpion venom serum(AScVS). Drug: T.Prazosin Drug: AScVS + Prazosin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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
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Enrollment: | 81 |
Study Start Date: | September 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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AScVS: Active Comparator
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.
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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 |
Prazosin.: Active Comparator
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.
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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.
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AScVS + Prazosin: Active Comparator
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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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.
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Ages Eligible for Study: | 12 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: (All of the following)
Criteria Grade Symptoms
Sweating 0 Limited to the extremity of the sting site.
Pulse rate 0 70- 90
Respiratory rate 0 < 20
Blood pressure 0 120/80
CNS effects 0 No sensory involvement
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)
India, Maharashtra | |
Vijayshree Hospital,At & Po.Umroli,Tal. Chiplun. | |
Dist. Ratnagiri., Maharashtra, India, 415702 | |
Mangaon cottage hospital, Mangaon. | |
Dist. Raigad., Maharashtra, India, 402104 | |
Natu Hospital | |
Chiplun, Maharashtra, India, 415605 | |
Sane Hospital | |
Chiplun, Maharashtra, India, 415605 | |
Kushte Hospital | |
Chiplun, Maharashtra, India, 415605 |
Principal Investigator: | Dr Vivek S Natu, M.S. | Vijayshree Hospital, Umroli, Chiplun, Ratnagiri, Maharashtra, India. |
Study Chair: | Dr. Santosh Kamerkar, M.S | Cottage Hospital Mangaon,Raigad,Maharashtra, India |
Study Chair: | Dr. Geeta Kadam, M.B.B.S. | Cottage Hospital Mangaon,Raigad,Maharashtra, India |
Study Chair: | Dr. Vidya Kamble, M.B.B.S. | Cottage Hospital Mangaon,Raigad,Maharashtra, India |
Study Chair: | Dr. Vikas Natu, MBBS DCH | Natu Hospital Chiplun,Ratnagiri, Maharashtra,India |
Study Chair: | Dr. Sanjeev Sane, MBBS DCH | Sane Hospital Chiplun,Ratnagiri, Maharashtra,India |
Study Chair: | Dr. Rajesh Kushte, MBBSDCH | Kushte Hospital Chiplun,Ratnagiri, Maharashtra,India |
Study Chair: | Dr. Sunil Thatte, M.D. | Attending physician at Natu, Sane & Kushte Hospital Chiplun,Ratnagiri, Maharashtra,India |
Study Chair: | Dr. Uchil Dinesh, Ph.D. | A.R.C. K.E.M. Hospital Mumbai,Maharashtra,India |
Study Chair: | Dr. Nirmala Rege, M.D. | A.R.C. K.E.M. Hospital Mumbai,Maharashtra,India |
Study Director: | Dr. Ravindra Bapat, M.S. | K.E.M. Hospital Mumbai,Maharashtra,India |
Responsible Party: | Vijayshree hospital, Umroli, Chiplun, Ratnagiri, Maharashtra, India. 415702. ( Dr. Vivek Shridhar Natu. ) |
Study ID Numbers: | AScVS vs Prazosin |
Study First Received: | September 14, 2008 |
Last Updated: | September 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00753064 History of Changes |
Health Authority: | United States: Federal Government; India: Ministry of Health |
Red Scorpion envenomation Composite clinical scoring system AScVS Prazosin Superiority |
Neurotransmitter Agents Adrenergic Agents Prazosin Adrenergic Antagonists |
Cardiovascular Agents Adrenergic alpha-Antagonists Antihypertensive Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Prazosin Therapeutic Uses Physiological Effects of Drugs |
Adrenergic Antagonists Cardiovascular Agents Adrenergic alpha-Antagonists Antihypertensive Agents Pharmacologic Actions |