Clinical trial · Interventional
Acmella Oleracea in the Analgesia of the Digital Rectal Examination
NCT05141864CI-TRIAL-00055350completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Analgesia in the Digital Rectal Examination | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acmella oleracea gel | Biological | — | UNRESOLVED |
| Lidocaine 2 % Topical Cream | Drug | — | UNRESOLVED |
| Ultrasound gel | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Acmella oleracea gel group
- description
- Formulation with Acmella oleracea will be used during the digital rectal examination.
- interventionNames
- Biological: Acmella oleracea gel
- type
- ACTIVE_COMPARATOR
- label
- Lidocaina gel group
- description
- The lidocaine gel will be used during the digital rectal examination.
- interventionNames
- Drug: Lidocaine 2 % Topical Cream
- type
- PLACEBO_COMPARATOR
- label
- Ultrasound gel group
- description
- The ultrasound gel will be used during the digital rectal examination.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.