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临床试验/NCT02792972
NCT02792972已完成不适用

Antiseptic and Analgesic Action Acmella Oleracea Skin: Randomized Clinical Trial

Ana Beatriz Alkimim Teixeira Loyola0 个研究点目标入组 60 人开始时间: 2015年9月1日最近更新:
适应症

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

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

发起方
Ana Beatriz Alkimim Teixeira Loyola
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ana Beatriz Alkimim Teixeira Loyola

MD

Universidade do Vale do Sapucai

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