Acmella Oleracea in the Analgesia of the Digital Rectal Examination

NCT05141864 | Completed Phase 1 DMC

• 1 other identifier: Acmella
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia in the Digital Rectal Examination

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day (After the digital rectal examination)

Study Arms (3)

Acmella oleracea gel group

ACTIVE COMPARATOR

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

Biological: Acmella oleracea gel

Lidocaina gel group

ACTIVE COMPARATOR

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

Drug: Lidocaine 2 % Topical Cream

Ultrasound gel group

PLACEBO COMPARATOR

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

Other: Ultrasound gel

Interventions

Acmella oleracea gel BIOLOGICAL

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

Acmella oleracea gel group

Lidocaine 2 % Topical Cream DRUG

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

Lidocaina gel group

Ultrasound gel OTHER

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

Ultrasound gel group

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade do Vale do Sapucai: lead

Study Sites (1)

Universidade do Vale do Sapucaí

Pouso Alegre, Minas Gerais, 37550-000, Brazil

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Pain; Agnosia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Fabrizia S Guerrieri

  Vale do Sapucaí University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 20, 2021
• First Posted: December 2, 2021
• Study Start: March 5, 2021
• Primary Completion: June 5, 2021
• Study Completion: November 5, 2021
• Last Updated: December 2, 2021

Record last verified: 2021-11

Locations

BR (1)