Alpha-Bisabolol Gel With Antihistamine Action
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
- 2
- 主要终点
- Measure of the area (cm2) sensitized with histamine only
研究概览
简要总结
It will be developed and evaluated the antihistamine potential of a gel containing alpha-bisabolol. Method: Interventional and cross-sectional study, with convenience sampling, conducted with 20 volunteers. The forearm will be sensitized at four points (A, B, C and D). Point A: positive control will be sensitized with a drop of histamine at a concentration of 10 mg / Ml. Point B: histamine will apply and immediately after, the alpha bisabolol gel with a concentration of 0.5%. Point C: histamine and gel with 2.5% alpha-bisabolol will apply. Point D will be sensitized with a drop of histamine and 5.0% alpha-bisabolol gel. The test reading at each point will occur 15 minutes after the procedure. For the analysis of the results, the T Test will be applied.
详细描述
Context:. Phytotherapy has been widely used to treat health with a prophylactic, curative and palliative purpose due to its easy access and low cost when compared to other available drug forms. Some plant species have antiallergic and anti-inflammatory properties that can be used to help contain signs and damage in allergic reactions, triggered mainly by histamine such as: pain, redness, heat and edema. Alpha-bisabolol, extracted from Candeia, has several applications in the treatment of illnesses, however, there are no studies on the therapeutic potential for antihistamine. Objective: To develop and evaluate the antihistamine potential of a gel containing alpha-bisabolol. Method: Pilot study, interventional, cross-sectional study, with convenience sampling, conducted with 20 volunteers. The forearm will be sensitized at four points (A, B, C and D). Point A: positive control sensitized with a drop of histamine at a concentration of 10 mg / Ml. Point B: histamine will be applied and immediately after, the alpha bisabolol gel with a concentration of 0.5%. Point C: histamine and gel with 2.5% alpha-bisabolol will be applied. Point D will be sensitized with a drop of histamine and 5.0% alpha-bisabolol gel. The test reading at each point will occur 15 minutes after the procedure. For the analysis of the results, the T Test will be applied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •participants without allergy-related diseases, non-pregnant women and who agreed to cooperate in carrying out the research by signing the consent form aged between 18 and 60 years of both sexes.
排除标准
- •participants who had a history of previous anaphylaxis, extensive dermatitis, use of antihistamines, colds or steroids.
- •participants who had a negative reaction to histamine and/or withdrew their consent at any stage of the study.
结局指标
主要结局
Measure of the area (cm2) sensitized with histamine only
时间窗: 15 minutes
Positive control sensitized with a drop of histamine at a concentration of 10 mg / Ml, and after 15 minutes the area sensitized will be measure
Measure of the area (cm2) sensitized by histamine treated with 0,5% Alpha bisabolol
时间窗: 15 minutes
Histamine will be applied and immediately after, the alpha bisabolol gel with a concentration of 0.5%, and after 15 minutes the area sensitized will be measure
Measure of the area sensitized by histamine treated with 2,5% Alpha bisabolol
时间窗: 15 minutes
Histamine will be applied and immediately after, the alpha bisabolol gel with a concentration of 2,5% will applied, and after 15 minutes the area sensitized will be measure
Measure of the area (cm2) sensitized by histamine treated with 5% Alpha bisabolol
时间窗: 15 minutes
It will be sensitized with a drop of histamine and immediately with 5.0% alpha-bisabolol gel, and after 15 minutes the area sensitized will be measure
次要结局
未报告次要终点
研究者
Adriana Rodrigues dos Anjos Mendonça
Principal Investigator
Universidade do Vale do Sapucai