Efficacy and safety evaluation of "Padra Serum Alborz" vs "Razi Vaccine and Serum Research Institute" scorpion antivenom productions

Phase 3 clinical trial for non-inferiority evaluation of efficacy and safety of scorpion antivenom "Padra Serum Alborz " production vs "Razi Vaccine and Serum Research Institute" in the treatment of scorpion sting victims age of 2 to 60

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180515039672N1

Enrollment

Registered

2019-01-28

Start date

2019-01-10

Completion date

Unknown

Last updated

2019-05-21

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

Conditions

Scorpion sting.

Interventions

Intervention 1: Intervention group: 1 to 3, 5ml vials (by physician diagnosis based on initial signs) of Scorpion Antivenom (Padra Serum Alborz Production) with dose of 10 LD50/ml for 20 to 30 minutes

Eligibility

Sex/Gender

All

Age

2 Years to 60 Years

Inclusion criteria

Inclusion criteria: Scorpion sting victims age of 2 to 60 Hospital entrance at maximum 6 hours after scorpion sting Signs of systemic scorpion envenomation or having the Indication for Antivenom Infusion

Exclusion criteria

Exclusion criteria: History of allergic reactions to plasma derived productions History of severe allergic diseases such as atopic asthma Present of systemic diseases such as cardiovascular and kidney diseases Pregnant and nursing women

Design outcomes

Primary

Measure	Time frame
Proportion of victims with alleviation of scorpion envenomation symptoms. Timepoint: 12 hours after antivenom infusion. Method of measurement: Symptom alleviation: Alleviate the initial symptoms from "severe" to "moderate to mild" by the physician diagnosis.	—

Secondary

Measure	Time frame
The mean time of scorpion envenomation symptoms duration alleviation. Timepoint: 24 hours after antivenom infusion. Method of measurement: The time recording.;The incidence of anaphylactic reactions. Timepoint: During the study time. Method of measurement: Reporting the incidence proportion.;The Serum Sickness incidence. Timepoint: During the study time. Method of measurement: Reporting the incidence proportion.;The incidence of any other adverse events. Timepoint: During the study time. Method of measurement: Reporting the incidence proportion.;Duration of the victims' hospitalization. Timepoint: During the study time. Method of measurement: The time recording.	—

Measure

Time frame

The mean time of scorpion envenomation symptoms duration alleviation. Timepoint: 24 hours after antivenom infusion. Method of measurement: The time recording.;The incidence of anaphylactic reactions. Timepoint: During the study time. Method of measurement: Reporting the incidence proportion.;The Serum Sickness incidence. Timepoint: During the study time. Method of measurement: Reporting the incidence proportion.;The incidence of any other adverse events. Timepoint: During the study time. Method of measurement: Reporting the incidence proportion.;Duration of the victims' hospitalization. Timepoint: During the study time. Method of measurement: The time recording.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Amini Pouya

Padra Serum Alborz

m.amini@artapharmed.com+98 26 4533 4189

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026