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AScVS and/ or Prazosin for Scorpion Envenomation

This study has been completed.
Sponsor:
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
  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
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
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.
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)
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.
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)
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.
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:
  • AScVS (Haffkine)
  • T. Prazosin (sun pharma)

  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)

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753064

Locations
India
Kushte Hospital
Chiplun, Maharashtra, India, 415605
Natu Hospital
Chiplun, Maharashtra, India, 415605
Sane 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.:
Red Scorpion envenomation
Composite clinical scoring system
AScVS
Prazosin
Superiority

Additional relevant MeSH terms:
Poisoning
Chemically-Induced Disorders
Prazosin
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014