Acmella Oleracea in the Analgesia of the Digital Rectal Examination

Sponsor

Universidade do Vale do Sapucai (Other)

Overall Status

Completed

CT.gov ID

NCT05141864

Collaborator

(none)

150

Enrollment

Location

Arms

Actual Duration (Months)

18.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia in the Digital Rectal Examination	Biological: Acmella oleracea gel Drug: Lidocaine 2 % Topical Cream Other: Ultrasound gel	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Acmella Oleracea in the Analgesia of the Digital Rectal Examination

Actual Study Start Date :

Mar 5, 2021

Actual Primary Completion Date :

Jun 5, 2021

Actual Study Completion Date :

Nov 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Acmella oleracea gel group Formulation with Acmella oleracea will be used during the digital rectal examination.	Biological: Acmella oleracea gel Study group will use Acmella oleracea gel during the digital rectal examination.
Active Comparator: Lidocaina gel group The lidocaine gel will be used during the digital rectal examination.	Drug: Lidocaine 2 % Topical Cream Control group will use lidocaine 2% gel during the digital rectal examination.
Placebo Comparator: Ultrasound gel group The ultrasound gel will be used during the digital rectal examination.	Other: Ultrasound gel Control group will use ultrasound gel during the digital rectal examination.

Arm

Intervention/Treatment

Active Comparator: Acmella oleracea gel group

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

Biological: Acmella oleracea gel

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

Active Comparator: Lidocaina gel group

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

Drug: Lidocaine 2 % Topical Cream

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

Placebo Comparator: Ultrasound gel group

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

Other: Ultrasound gel

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

Outcome Measures

Primary Outcome Measures

Evaluate the pain [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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