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NCT05141864

Acmella Oleracea in the Analgesia of the Digital Rectal Examination

Completed Phase 1 Last updated 2 December 2021
What this trial tests

Phase 1 trial testing Acmella oleracea gel in Analgesia in the Digital Rectal Examination in 150 participants. Completed in 5 November 2021.

Timeline
5 March 2021
Primary endpoint
5 June 2021
5 November 2021

Quick facts

Lead sponsorUniversidade do Vale do Sapucai
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeother
Enrollment150
Start date5 March 2021
Primary completion5 June 2021
Estimated completion5 November 2021
Sites1 location across Brazil

Drugs / interventions tested

Conditions studied

Sponsor

Universidade do Vale do Sapucai — full company profile →

Who can join

Adults 45 to 80, male only, with Analgesia in the Digital Rectal Examination. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other Universidade do Vale do Sapucai trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05141864.

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