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NCT Number: NCT05141864

Acmella Oleracea in the Analgesia of the Digital Rectal Examination

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.

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Key information

Conditions

Analgesia in the Digital Rectal Examination Agnosia Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms

Age range

45 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Universidade do Vale do Sapucaí

Pouso Alegre, Minas Gerais, 37550-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acmella oleracea gel

Biological

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

Lidocaine 2 % Topical Cream

Drug

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

Ultrasound gel

Other

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

Primary outcomes

  1. Evaluate the pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidade do Vale do Sapucai

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 2, 2021
Registry last updated
Dec 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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