A Comparative Study on Local Allergic Responses of Bee Venom and Essential Bee Venom Pharmacopuncture
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Wheal and erythema
研究概览
简要总结
This double-blinded randomized clinical trial investigates any differences in allergic responses elicited by Bee Venom (BV) and Essential Bee Venom (eBV).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Bee Venom (BV) (Drug)
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.
干预措施: Essential Bee Venom (e-BV) (Drug)
结局指标
主要结局
Wheal and erythema
时间窗: 24 hours after intervention
traced on adhesive, transparent films and measured with 0.01mm calipher
Visual Analog Scale(VAS) on Pain
时间窗: 48 hours after intervention
Visual Analog Scale on Pain
次要结局
- Visual Analog Scale(VAS) on Pain(0, 2, 6, 24, 72, 96, 120, 144 hours after intervention)
- Visual Analog Scale(VAS) for Wheal response(0,0.5, 2, 6, 24, 48, 72, 96, 120, 144 hours after intervention)
- Visual Analog Scale(VAS) for Skin irritation(0,0.5, 2, 6, 24, 48, 72, 96, 120, 144 hours after intervention)
- Wheal and erythema(0, 0.5, 6, 24, 72 hours after intervention)
- Adverse events(0, 6, 24, 72 hours after intervention)