Antiseptic and Analgesic Action Acmella Oleracea Skin: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- The degree of pain in 15 healthy volunteers will be measured by the visual numeric scale (VNS) standard immediately after the venipuncture procedure.
研究概览
简要总结
Context: Research on natural products with therapeutic, analgesic or antimicrobial purpose should be encouraged to create new drugs. Acmella oleracea, typical plant of the Northern region of the country and popularly known as jambu, has aroused the interest of researchers because of its therapeutic potential. Objective: To evaluate the potential topical analgesic and antimicrobial of Acmella oleracea plant extract from the skin antisepsis in venipuncture procedures. Methods: This is a clinical, randomized, controlled trial with healthy volunteers recruited at the Clinic I of the collection of biological materials sector of the Hospital das Clinicas Samuel Libânio, in Pouso Alegre-MG. The plant extract A. oleracea manipulated with Transcutol® and 70% alcohol were used in the volunteers before the venipuncture procedure as allocation in study groups. Held collection of skin microbiota by the swab technique and the end of the venipuncture procedure was applied to the volunteer, the visual numeric scale (VNS) standard to determine the degree of pain.
详细描述
Context: Research on natural products with therapeutic, analgesic or antimicrobial purpose should be encouraged to create new drugs. Acmella oleracea, typical plant of the Northern region of the country and popularly known as jambu, has aroused the interest of researchers because of its therapeutic potential. Objective: To evaluate the potential topical analgesic and antimicrobial of Acmella oleracea plant extract from the skin antisepsis in venipuncture procedures. Methods: This is a clinical, randomized, controlled trial with healthy volunteers recruited at the Clinic I of the collection of biological materials sector of the Hospital das Clinicas Samuel Libânio, in Pouso Alegre-MG. The plant extract A. oleracea manipulated with Transcutol® and 70% alcohol were used in the volunteers before the venipuncture procedure as allocation in study groups. Held collection of skin microbiota by the swab technique and the end of the venipuncture procedure was applied to the volunteer, the visual numeric scale (VNS) standard to determine the degree of pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •healthy volunteers
- •without restriction as to ethnicity
- •educational level and social class who agreed to participate by signing the Informed Consent and Informed (IC )
排除标准
- •pregnant women (due to contractile properties that can cause )
- •cancer patients
- •chronic and refusal to participate in the study kidney
结局指标
主要结局
The degree of pain in 15 healthy volunteers will be measured by the visual numeric scale (VNS) standard immediately after the venipuncture procedure.
时间窗: 1 day
The skin microflora in 15 healthy volunteers will be measured counted the microorganism isolated by swab technique and plated on plates containing the medium Standard Methods Agar (PCA).
时间窗: 1 day
次要结局
未报告次要终点
研究者
Ana Beatriz Alkimim Teixeira Loyola
MD
Universidade do Vale do Sapucai
