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Acmella Oleracea in the Analgesia of the Digital Rectal Examination

NCT05141864 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-12-02

No results posted yet for this study

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.

Conditions

  • Analgesia in the Digital Rectal Examination

Interventions

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.

Sponsors & Collaborators

  • Universidade do Vale do Sapucai

    lead OTHER

Principal Investigators

  • Fabrizia S Guerrieri · Vale do Sapucaí University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-05
Primary Completion
2021-06-05
Completion
2021-11-05

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05141864 on ClinicalTrials.gov