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Acmella Oleracea in the Analgesia of the Digital Rectal Examination

Primary Purpose

Analgesia in the Digital Rectal Examination

Status

Completed

Phase

Phase 1

Locations

Brazil

Study Type

Interventional

Intervention

Acmella oleracea gel

Lidocaine 2 % Topical Cream

Ultrasound gel

About this trial

This is an interventional other trial for Analgesia in the Digital Rectal Examination focused on measuring Prostatic neoplasms, Digital Rectal Examination, Phytotherapy, Pain, Analgesia, Spilanthes oleracea

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Universidade do Vale do Sapucaí

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Acmella oleracea gel group

Lidocaina gel group

Ultrasound gel group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Evaluate the pain

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05141864

First Posted

November 20, 2021

Last Updated

December 1, 2021

Sponsor

Universidade do Vale do Sapucai

1. Study Identification

Unique Protocol Identification Number

NCT05141864

Brief Title

Acmella Oleracea in the Analgesia of the Digital Rectal Examination

Official Title

Acmella Oleracea in the Analgesia of the Digital Rectal Examination

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

March 5, 2021 (Actual)

Primary Completion Date

June 5, 2021 (Actual)

Study Completion Date

November 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidade do Vale do Sapucai

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Analgesia in the Digital Rectal Examination

Keywords

Prostatic neoplasms, Digital Rectal Examination, Phytotherapy, Pain, Analgesia, Spilanthes oleracea

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acmella oleracea gel group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Lidocaina gel group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Ultrasound gel group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Acmella oleracea gel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Lidocaine 2 % Topical Cream

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Ultrasound gel

Intervention Description

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

Primary Outcome Measure Information:

Title

Evaluate the pain

Description

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.

Time Frame

1 day (After the digital rectal examination)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fabrizia S Guerrieri

Organizational Affiliation

Vale do Sapucaí University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universidade do Vale do Sapucaí

City

Pouso Alegre

State/Province

Minas Gerais

ZIP/Postal Code

37550-000

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

Acmella Oleracea in the Analgesia of the Digital Rectal Examination

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