A Comparative Study on Local Allergic Responses of Bee Venom and Essential Bee Venom Pharmacopuncture
- Conditions
- Healthy Volunteers
- Interventions
- Drug: Bee Venom (BV)Drug: Essential Bee Venom (e-BV)
- Registration Number
- NCT02364349
- Lead Sponsor
- Jaseng Hospital of Korean Medicine
- Brief Summary
This double-blinded randomized clinical trial investigates any differences in allergic responses elicited by Bee Venom (BV) and Essential Bee Venom (eBV).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bee Venom (BV) group Bee Venom (BV) 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. essential Bee Venom (eBV) group Essential Bee Venom (e-BV) 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.
- Primary Outcome Measures
Name Time Method Wheal and erythema 24 hours after intervention traced on adhesive, transparent films and measured with 0.01mm calipher
Visual Analog Scale(VAS) on Pain 48 hours after intervention Visual Analog Scale on Pain
- Secondary Outcome Measures
Name Time Method Visual Analog Scale(VAS) on Pain 0, 2, 6, 24, 72, 96, 120, 144 hours after intervention Visual Analog Scale on Pain,
Visual Analog Scale(VAS) for Wheal response 0,0.5, 2, 6, 24, 48, 72, 96, 120, 144 hours after intervention Wheal response
Visual Analog Scale(VAS) for Skin irritation 0,0.5, 2, 6, 24, 48, 72, 96, 120, 144 hours after intervention Skin irritation
Wheal and erythema 0, 0.5, 6, 24, 72 hours after intervention traced on adhesive, transparent films and measured with 0.01mm calipher
Adverse events 0, 6, 24, 72 hours after intervention General skin irritation, Heat flush, Nausea, Vomiting, Pain, Headache, Dizziness, Fatigue
Trial Locations
- Locations (1)
Jaseng Hospital of Korean Medicine
🇰🇷Seoul, Gangnam-Gu, Korea, Republic of