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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acmella oleracea gel group | Active Comparator | Formulation with Acmella oleracea will be used during the digital rectal examination. |
|
| Lidocaina gel group | Active Comparator | The lidocaine gel will be used during the digital rectal examination. |
|
| Ultrasound gel group | Placebo Comparator | The ultrasound gel will be used during the digital rectal examination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acmella oleracea gel | Biological | Study group will use Acmella oleracea gel during the digital rectal examination. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day (After the digital rectal examination) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabrizia S Guerrieri | Vale do Sapucaà University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade do Vale do Sapucaà | Pouso Alegre | Minas Gerais | 37550-000 | Brazil |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Lidocaine 2 % Topical Cream | Drug | Control group will use lidocaine 2% gel during the digital rectal examination. |
|
| Ultrasound gel | Other | Control group will use ultrasound gel during the digital rectal examination. |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| Aniline Compounds |
| D000588 | Amines |