AScVS and/ or Prazosin for Scorpion Envenomation
This study has been completed.
Sponsor:
Haffkine Bio-Pharmaceutical Corporation Ltd.
Information provided by:
Haffkine Bio-Pharmaceutical Corporation Ltd.
ClinicalTrials.gov Identifier:
NCT00753064
First received: September 14, 2008
Last updated: September 15, 2008
Last verified: September 2008
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Purpose
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 + Prazosin Therapy. |
Resource links provided by NLM:
Further study details as provided by Haffkine Bio-Pharmaceutical Corporation Ltd.:
Primary Outcome Measures:
- Superiority of AScVS and AScVS+Prazosin was confirmed over use of Prazosin alone. [ Time Frame: 1year 4 months. ] [ Designated as safety issue: Yes ]
| 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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Active Comparator: AScVS
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 Other Name: AScVS(Haffkine)
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Active Comparator: 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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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.
Other Name: T.Prazosin (sun pharma)
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Active Comparator: 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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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.
Other Names:
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Show Detailed Description Eligibility| Ages Eligible for Study: | 12 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria: (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 Criteria: (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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00753064
Locations
| India | |
| Natu Hospital | |
| Chiplun, Maharashtra, India, 415605 | |
| Sane Hospital | |
| Chiplun, Maharashtra, India, 415605 | |
| Kushte Hospital | |
| Chiplun, Maharashtra, India, 415605 | |
| Mangaon cottage hospital, Mangaon. | |
| Dist. Raigad., Maharashtra, India, 402104 | |
| Vijayshree Hospital,At & Po.Umroli,Tal. Chiplun. | |
| Dist. Ratnagiri., Maharashtra, India, 415702 | |
Sponsors and Collaborators
Haffkine Bio-Pharmaceutical Corporation Ltd.
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Dr. Vivek Shridhar Natu., Vijayshree hospital, Umroli, Chiplun, Ratnagiri, Maharashtra, India. 415702. |
| ClinicalTrials.gov Identifier: | NCT00753064 History of Changes |
| Other Study ID Numbers: | AScVS vs Prazosin |
| Study First Received: | September 14, 2008 |
| Last Updated: | September 15, 2008 |
| Health Authority: | United States: Federal Government India: Ministry of Health |
Keywords provided by Haffkine Bio-Pharmaceutical Corporation Ltd.:
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Red Scorpion envenomation Composite clinical scoring system AScVS Prazosin Superiority |
Additional relevant MeSH terms:
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Prazosin Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Adrenergic alpha-1 Receptor Antagonists |
Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013