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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Bee Venom (BV); Drug: Essential Bee Venom (e-BV)

Detailed Description

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
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangnam-Gu
    • Seoul, Gangnam-Gu, Korea, Republic of, 135-896
      • Jaseng Hospital of Korean Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bee Venom (BV) group; All subjects are injected with Bee Venom (BV, intervention), randomly assigned to the right or left forearm. Raw BV used dried BV prepared through collection from bee venom sacs and removal of impurities. The BV administration site on each subject was on the palmar side of the designated arm 5 cm below the middle of the elbow crease as it is convenient for observation and has high responsiveness. Pharmacopuncture sessions were also conducted in the morning for higher responsiveness.	Drug: Bee Venom (BV); Raw Bee Venom; Other Names: Bee Venom pharmacopuncture; Bee Venom injection
Experimental: essential Bee Venom (eBV) group; All subjects are injected with essential Bee Venom (eBV, intervention), randomly assigned to the right or left forearm. eBV was prepared through the following methods: BV was collected from bee venom sacs and dried. LC/MS was used to analyze subdivisions of dried BV dissolved in purified water and passed through a sephadex G-25 column to collect histamine-free units. Collected units were filtered to eliminate allergenic substances including PLA2 of molecular weight 10 kDa or higher. The eBV administration site on each subject was on the palmar side of the designated arm 5 cm below the middle of the elbow crease as it is convenient for observation and has high responsiveness. Pharmacopuncture sessions were also conducted in the morning for higher responsiveness.	Drug: Essential Bee Venom (e-BV); Bee venom without Hyaluronidase, Lysophospholipase, α-D-glucosidase, PLA2, Adolapin; Other Names: Essential Bee Venom pharmacopuncture; Essential Bee Venom injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale(VAS) on Pain	Visual Analog Scale on Pain	0.5 hours after intervention
Wheal and erythema	traced on adhesive, transparent films and measured with 0.01mm calipher	24 hours after intervention
Visual Analog Scale(VAS) on Pain	Visual Analog Scale on Pain	48 hours after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale(VAS) on Pain	Visual Analog Scale on Pain,	0, 2, 6, 24, 72, 96, 120, 144 hours after intervention
Visual Analog Scale(VAS) for Wheal response	Wheal response	0,0.5, 2, 6, 24, 48, 72, 96, 120, 144 hours after intervention
Visual Analog Scale(VAS) for Skin irritation	Skin irritation	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	0, 0.5, 6, 24, 72 hours after intervention
Adverse events	General skin irritation, Heat flush, Nausea, Vomiting, Pain, Headache, Dizziness, Fatigue	0, 6, 24, 72 hours after intervention

Collaborators and Investigators

• Sponsor: Jaseng Hospital of Korean Medicine
• Investigators: Study Chair: Joon-Shik SHIN, MD, Jaseng Hospital of Korean Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: January 28, 2015
• First Submitted That Met QC Criteria: February 10, 2015
• First Posted (Estimate): February 18, 2015

Study Record Updates

• Last Update Posted (Actual): November 7, 2018
• Last Update Submitted That Met QC Criteria: November 5, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: JS-CT-2015-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No