Analgesia in the Digital Rectal ExaminationPhase 1NCT05141864
Acmella Oleracea in the Analgesia of the Digital Rectal Examination
A Phase 1 study testing Acmella oleracea gel, Lidocaine 2 % Topical Cream and Ultrasound gel in people with Analgesia in the Digital Rectal Examination, run by Universidade do Vale do Sapucai at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Analgesia in the Digital Rectal Examination
- What is being tested?
- Acmella oleracea gel, Lidocaine 2 % Topical Cream and Ultrasound gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Mar 2021to 5 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male patients
- Patients to agree to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade do Vale do Sapucaí
Pouso Alegre, Minas Gerais, 37550-000
About this study
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.
Read the detailed 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.
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.
- Being tested
- Acmella oleracea gel, Lidocaine 2 % Topical Cream, Ultrasound gel
- Keywords
- Prostatic neoplasms, Digital Rectal Examination, Phytotherapy, Pain, Analgesia, Spilanthes oleracea
- Medical subject headings
- Prostatic Neoplasms, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acmella oleracea gelBiological
Study group will use Acmella oleracea gel during the digital rectal examination.
Lidocaine 2 % Topical CreamDrug
Control group will use lidocaine 2% gel during the digital rectal examination.
Ultrasound gelOther
Control group will use ultrasound gel during the digital rectal examination.
| Study group | Role | What they receive |
|---|---|---|
| Acmella oleracea gel group | Active comparator | Formulation with Acmella oleracea will be used during the digital rectal examination. Receives: Biological: Acmella oleracea gel |
| Lidocaina gel group | Active comparator | The lidocaine gel will be used during the digital rectal examination. Receives: Drug: Lidocaine 2 % Topical Cream |
| Ultrasound gel group | Placebo comparator | The ultrasound gel will be used during the digital rectal examination. Receives: Other: Ultrasound gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day (After the digital rectal examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start5 Mar 2021
- Primary completion5 Jun 2021
- Study completion5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia in the Digital Rectal ExaminationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Sapucai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrizia Serra Pereira Guerrieri, Universidade do Vale do Sapucai
- Investigators
- Fabrizia S Guerrieri, Principal investigator, Vale do Sapucaí University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141864
- Sponsor's protocol ID
- Acmella
- Status last verified
- Nov 2021
- First submitted
- 20 Nov 2021
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acmella Oleracea in the Analgesia of the Digital Rectal Examination
- ClinicalTrials.gov ID
- NCT05141864
- Acronym / sponsor ID
- Acmella
- Keywords
- Prostatic neoplasms, Digital Rectal Examination, Phytotherapy, Pain, Analgesia, Spilanthes oleracea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Universidade do Vale do SapucaiUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 5 Jun 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acmella oleracea gel group | Active comparator | Biological: Acmella oleracea gelFormulation with Acmella oleracea will be used during the digital rectal examination. |
| Lidocaina gel group | Active comparator | Drug: Lidocaine 2 % Topical CreamThe lidocaine gel will be used during the digital rectal examination. |
| Ultrasound gel group | Placebo comparator | Other: Ultrasound gelThe ultrasound gel will be used during the digital rectal examination. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male patients
- Patients to agree to participate in the study
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acmella oleracea gelStudy group will use Acmella oleracea gel during the digital rectal examination. | Biological | Acmella oleracea gel group |
| Lidocaine 2 % Topical CreamControl group will use lidocaine 2% gel during the digital rectal examination. | Drug | Lidocaina gel group |
| Ultrasound gelControl group will use ultrasound gel during the digital rectal examination. | Other | Ultrasound gel group |
Primary outcome
Evaluate the pain
Time frame: 1 day (After the digital rectal examination)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrizia S Guerrieri principal investigator
Vale do Sapucaí University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acmella oleracea gel, Lidocaine 2 % Topical Cream and Ultrasound gel in people with Analgesia in the Digital Rectal Examination, run by Universidade do Vale do Sapucai at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the pain (time frame: 1 day (After the digital rectal examination)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021.