Acmella Oleracea in the Analgesia of the Digital Rectal Examination
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Evaluate the pain
研究概览
简要总结
The aim of the study is to develop an herbal gel based on Acmella oleracea and do a comparative analysis to evaluate the intensity of pain during the digital rectal examination comparing to lidocaine gel group and ultrasound gel group.
详细描述
The aim of the study is to develop an herbal gel based on Acmella oleracea and do a comparative analysis to evaluate the intensity of pain during the digital rectal examination comparing to lidocaine gel group and ultrasound gel group.
We are conducting a randomized, controlled, single-blind clinical trial of man undergoing to digital rectal examination, with 150 participants. Will be recruit at the Urologic Clinic of the Samuel Libânio Clinical Hospital and Urologic Clinic CISAMESP in Pouso Alegre. Participants divided into three groups, A. oleracea gel group, lidocaine gel group and ultrasound gel group. The digital rectal examination always performed by the same doctor, on the same position. A visual analogue scale (VAS) will be the standard method to evaluate the pain levels. The VAS will be explained to all patients, 0 = no pain and 10 = the most severe pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male patients
- •Patients to agree to participate in the study
排除标准
- •Diabetic, chronic kidney disease, with urogenital infections, using an indwelling urinary catheter, with history of anorectal diseases or surgeries, psychiatric patients and who refused to participate in the research
研究组 & 干预措施
Acmella oleracea gel group
Formulation with Acmella oleracea will be used during the digital rectal examination.
干预措施: Acmella oleracea gel (Biological)
Lidocaina gel group
The lidocaine gel will be used during the digital rectal examination.
干预措施: Lidocaine 2 % Topical Cream (Drug)
Ultrasound gel group
The ultrasound gel will be used during the digital rectal examination.
干预措施: Ultrasound gel (Other)
结局指标
主要结局
Evaluate the pain
时间窗: 1 day (After the digital rectal examination)
A visual analogue scale (VAS) will be the standard method to evaluate the pain levels. The VAS will be explained to all patients, 0 = no pain and 10 = the most severe pain.
次要结局
未报告次要终点
研究者
Fabrizia Serra Pereira Guerrieri
Principal investigator
Universidade do Vale do Sapucai