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Acmella Oleracea in the Analgesia of the Digital Rectal Examination

NCT ID: NCT05141864

Last Updated: 2021-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-05

Study Completion Date

2021-11-05

Brief Summary

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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

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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

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Analgesia in the Digital Rectal Examination

Keywords

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Prostatic neoplasms Digital Rectal Examination Phytotherapy Pain Analgesia Spilanthes oleracea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Acmella oleracea gel group

Formulation with Acmella oleracea will be used during the digital rectal examination.

Group Type ACTIVE_COMPARATOR

Acmella oleracea gel

Intervention Type BIOLOGICAL

Study group will use Acmella oleracea gel during the digital rectal examination.

Lidocaina gel group

The lidocaine gel will be used during the digital rectal examination.

Group Type ACTIVE_COMPARATOR

Lidocaine 2 % Topical Cream

Intervention Type DRUG

Control group will use lidocaine 2% gel during the digital rectal examination.

Ultrasound gel group

The ultrasound gel will be used during the digital rectal examination.

Group Type PLACEBO_COMPARATOR

Ultrasound gel

Intervention Type OTHER

Control group will use ultrasound gel during the digital rectal examination.

Interventions

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Acmella oleracea gel

Study group will use Acmella oleracea gel during the digital rectal examination.

Intervention Type BIOLOGICAL

Lidocaine 2 % Topical Cream

Control group will use lidocaine 2% gel during the digital rectal examination.

Intervention Type DRUG

Ultrasound gel

Control group will use ultrasound gel during the digital rectal examination.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male patients
* Patients to agree to participate in the study

Exclusion Criteria

* 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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade do Vale do Sapucai

OTHER

Sponsor Role lead

Responsible Party

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Fabrizia Serra Pereira Guerrieri

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fabrizia S Guerrieri

Role: PRINCIPAL_INVESTIGATOR

Vale do Sapucaí University

Locations

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Universidade do Vale do Sapucaí

Pouso Alegre, Minas Gerais, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Acmella

Identifier Type: -

Identifier Source: org_study_id