A Phase 1 interventional study of Acmella oleracea gel and Lidocaine 2 % Topical Cream in Analgesia in the Digital Rectal Examination, sponsored by Universidade do Vale do Sapucai. Completed at 1 site in Brazil. Open to male participants aged 45 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-02.
Sponsored by Universidade do Vale do Sapucai · Phase 1, Interventional, and Other
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.
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 150 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
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Exclusion Criteria:
Formulation with Acmella oleracea will be used during the digital rectal examination.
Biological: Acmella oleracea gel
The lidocaine gel will be used during the digital rectal examination.
Drug: Lidocaine 2 % Topical Cream
The ultrasound gel will be used during the digital rectal examination.
Other: Ultrasound gel
Study group will use Acmella oleracea gel during the digital rectal examination.
Control group will use lidocaine 2% gel during the digital rectal examination.
Control group will use ultrasound gel during the digital rectal examination.
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.
Time frame: 1 day (After the digital rectal examination)
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Acmella oleracea · Lidocaine
Universidade do Vale do Sapucai