Healthy Volunteers
Conditions
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.
Interventions
DRUGBee Venom (BV)
Raw Bee Venom
DRUGEssential Bee Venom (e-BV)
Bee venom without Hyaluronidase, Lysophospholipase, α-D-glucosidase, PLA2, Adolapin
Sponsors
Jaseng Hospital of Korean Medicine
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 39 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale(VAS) on Pain | 0.5 hours after intervention | Visual Analog Scale on Pain |
| Wheal and erythema | 24 hours after intervention | traced on adhesive, transparent films and measured with 0.01mm calipher |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale(VAS) for Skin irritation | 0,0.5, 2, 6, 24, 48, 72, 96, 120, 144 hours after intervention | Skin irritation |
| Visual Analog Scale(VAS) on Pain | 0, 2, 6, 24, 72, 96, 120, 144 hours after intervention | Visual Analog Scale on Pain, |
| Adverse events | 0, 6, 24, 72 hours after intervention | General skin irritation, Heat flush, Nausea, Vomiting, Pain, Headache, Dizziness, Fatigue |
| Wheal and erythema | 0, 0.5, 6, 24, 72 hours after intervention | traced on adhesive, transparent films and measured with 0.01mm calipher |
| Visual Analog Scale(VAS) for Wheal response | 0,0.5, 2, 6, 24, 48, 72, 96, 120, 144 hours after intervention | Wheal response |
Countries
South Korea
Outcome results
None listed