A Comparative Study on Local Allergic Responses of Bee Venom and Essential Bee Venom Pharmacopuncture

Jaseng Hospital of Korean Medicine20 enrolled

Overview

This double-blinded randomized clinical trial investigates any differences in allergic responses elicited by Bee Venom (BV) and Essential Bee Venom (eBV).

This double-blinded randomized clinical trial investigates difference in allergic responses elicited by Bee Venom (BV) and Essential Bee Venom (eBV). Twenty healthy volunteers aged 20-40 years were randomly allocated to the 2 groups and administered eBV and BV on left and right forearm, respectively, in accordance with group allocation. Physician, participant, and outcome assessor were blinded to group allocation. Local pain, swelling, itching, redness, wheals and adverse reactions were recorded by timepoint before and after treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

Bee Venom (BV)DRUG

Raw Bee Venom

Essential Bee Venom (e-BV)DRUG

Bee venom without Hyaluronidase, Lysophospholipase, α-D-glucosidase, PLA2, Adolapin

Eligibility

Sex: ALLMin age: 20 YearsMax age: 39 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Individuals with no prior exposure to bee venom treatment * Healthy individuals of both genders, 20 to 39 years old * Individuals able to communicate their thoughts * Voluntary participants who have provided written consent Exclusion Criteria: * Individuals on medications for chronic diseases (i.e. hypertension, hyperlipidemia) * Individuals with past history of allergic dermatitis * Individuals with past history of adverse events following bee stings * Individuals with symptoms of common cold * Individuals with fear of bee venom intervention or those who refuse to participate

Locations (1)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, South Korea

Outcomes

Primary Outcomes

Visual Analog Scale(VAS) on Pain

Visual Analog Scale on Pain

Time frame: 0.5 hours after intervention

Wheal and erythema

traced on adhesive, transparent films and measured with 0.01mm calipher

Time frame: 24 hours after intervention

Visual Analog Scale(VAS) on Pain

Visual Analog Scale on Pain

Time frame: 48 hours after intervention

Secondary Outcomes

Visual Analog Scale(VAS) on Pain

Visual Analog Scale on Pain,

Time frame: 0, 2, 6, 24, 72, 96, 120, 144 hours after intervention

Visual Analog Scale(VAS) for Wheal response

Wheal response

Time frame: 0,0.5, 2, 6, 24, 48, 72, 96, 120, 144 hours after intervention

Visual Analog Scale(VAS) for Skin irritation

Skin irritation

Time frame: 0,0.5, 2, 6, 24, 48, 72, 96, 120, 144 hours after intervention

Wheal and erythema

traced on adhesive, transparent films and measured with 0.01mm calipher

Time frame: 0, 0.5, 6, 24, 72 hours after intervention

Adverse events

General skin irritation, Heat flush, Nausea, Vomiting, Pain, Headache, Dizziness, Fatigue

Time frame: 0, 6, 24, 72 hours after intervention

Data from ClinicalTrials.gov

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