NCT05141864

Acmella Oleracea in the Analgesia of the Digital Rectal Examination

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Universidade do Vale do Sapucai · Academic / Other
• Sex: Male
• Age: 45 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Analgesia in the Digital Rectal Examination

Interventions

Type	Name	Description
BIOLOGICAL	Acmella oleracea gel	Study group will use Acmella oleracea gel during the digital rectal examination.
DRUG	Lidocaine 2 % Topical Cream	Control group will use lidocaine 2% gel during the digital rectal examination.
OTHER	Ultrasound gel	Control group will use ultrasound gel during the digital rectal examination.

Timeline

• Start date: 2021-03-05
• Primary completion: 2021-06-05
• Completion: 2021-11-05
• First posted: 2021-12-02
• Last updated: 2021-12-02

Locations

1 site across 1 country: Brazil