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A Randomized open label clinical trial for evaluation of efficacy and safety of Prazosin and Prazosin with scorpion anti- Venom combination in victims of venomous scorpion ( Mesobuthus Tamulus ) sting.

A Randomized open label clinical trial for evaluation of efficacy and safety of Prazosin and Prazosin with scorpion anti- Venom combination in victims of venomous scorpion ( Mesobuthus Tamulus ) sting.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/000584
Enrollment
70
Registered
2010-09-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: scorpion antivenom: 30 ML intravenous route Control Intervention1: prazosin + scorpion antivenom: prazosin 250 microgram in children and 500 microgram in adult repeated 3 hourly interv

Sponsors

Nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients were eligible for enrollment if they reported to hospital with MT scorpion bite, with grade II, with an interval less than 6 hours between scorpion bite and hospitalization; age > 6 months. MT scorpion bite was confirmed if patient have seen red scorpion or brought the killed specimen or confirmed by showing him the hospital preserved specimen or photograph

Exclusion criteria

Exclusion criteria: Major exclusion criteria were, patient reporting after six hours of sting, pregnant women, previous history of taking prazosin or scorpion Antivenom, patient with history of bronchial asthma or previous history of allergic reaction to foreign serum and who refused to give consent.

Design outcomes

Primary

MeasureTime frame
ABSTRACT Objective- To evaluate the efficacy and safety of prazosin and prazosin with scorpion anti-venom combination in victims of envenomation by venomous scorpion ( Mesobuthus Tamulus ). Design ? Randomized open label trial Setting- Bawaskar Hospital and research Center Mahad Dist-Raigad Maharashtra India 402301 Participants- 70 patients with scorpion sting Grade II Intervention- We did an open ?label , randomized , controlled trial of scorpion anti-venom(SAV)+ prazosin versus prazosin alone for scorpion sting victims at general hospital. We compared the effectiveness of two regimens by assessing the clinical resolution of syndrome within 10 hours. 70 cases of scorpion sting of grade category were assigned to SAV+prazosin(n=35) or prazosin (n=35) by block randomization. The trial was registered with study protocol was approved by the independent Ethical Committee Mumbai Regd. No. 1433/1999 G.B.B.SD ( IEC/08/39). Main outcome measures. Patients from SAV +prazosin group recovered earlier (Mean [95%CI;8 hours6.5-9.5] as compared to prazosin treated patients (17.7 hours [15.4-19-9] ; t-test, p<0.001;( mean difference -9.7 hours[95% CI-6.9 to -12.4]. Number of cases deterioration to higher grade was similar in SAV+prazosin(4/35) and only prazosin(5/35); p<0.99. hypotension was reported in less number of patients(12/35,34.3% from SAV+prazosin than those treated with prazosin(19/35,54.3%), but it was statistically significant ;p=0.092. No difference was noted in change in blood pressure and pulse rate overtime between two groups.. Conclusion- We found clinically recovery is hastened by simultaneous administration of scorpion antivenom plus prazosin alone. Timepoint: resoluion of clnical syndrome at the end of ten hours of admission in both arm prazoisn +scorpion nativenom and Prazosin alone

Secondary

MeasureTime frame
Total dose of prazosin required , hypotension and deterortaion to higher gradesTimepoint: within 10 hours of administration of trila regimen prazosin + scorpion antivenom

Countries

India

Contacts

Public ContactDr Raakhi Tripathi
i_e_@vsnl.net022-2301 2223

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 29, 2026