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NCT05141864
Acmella Oleracea in the Analgesia of the Digital Rectal Examination
Phase 1 trial testing Acmella oleracea gel in Analgesia in the Digital Rectal Examination in 150 participants. Completed in 5 November 2021.
5 June 2021
Quick facts
| Lead sponsor | Universidade do Vale do Sapucai |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | other |
| Enrollment | 150 |
| Start date | 5 March 2021 |
| Primary completion | 5 June 2021 |
| Estimated completion | 5 November 2021 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Acmella oleracea gel — full drug profile →
- Lidocaine 2 % Topical Cream — full drug profile →
- Ultrasound gel
Conditions studied
- Analgesia in the Digital Rectal Examination — all drugs for Analgesia in the Digital Rectal Examination →
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.
Verify or expand the search:
- PubMed search for NCT05141864
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05141864 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universidade do Vale do Sapucai
- Last refreshed: 2 December 2021
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing