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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bee Venom (BV) group | Active Comparator | 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. |
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| essential Bee Venom (eBV) group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bee Venom (BV) | Drug | Raw Bee Venom |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joon-Shik SHIN, MD | Jaseng Hospital of Korean Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jaseng Hospital of Korean Medicine | Seoul | Gangnam-Gu | 135-896 | South Korea |
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| ID | Term |
|---|---|
| D001514 | Bee Venoms |
| ID | Term |
|---|---|
| D001180 | Arthropod Venoms |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
| D014118 | Toxins, Biological |
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| Essential Bee Venom (e-BV) | Drug | Bee venom without Hyaluronidase, Lysophospholipase, α-D-glucosidase, PLA2, Adolapin |
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| 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 |
| D001685 |
| Biological Factors |