Antiseptic and Analgesic Action Acmella Oleracea Skin: Randomized Clinical Trial

Study Overview
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Brief Summary
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Context: Research on natural products with therapeutic, analgesic or antimicrobial purpose should be encouraged to create new drugs. Acmella oleracea, typical plant of the Northern region of the country and popularly known as jambu, has aroused the interest of researchers because of its therapeutic potential. Objective: To evaluate the potential topical analgesic and antimicrobial of Acmella oleracea plant extract from the skin antisepsis in venipuncture procedures. Methods: This is a clinical, randomized, controlled trial with healthy volunteers recruited at the Clinic I of the collection of biological materials sector of the Hospital das Clinicas Samuel Libânio, in Pouso Alegre-MG. The plant extract A. oleracea manipulated with Transcutol® and 70% alcohol were used in the volunteers before the venipuncture procedure as allocation in study groups. Held collection of skin microbiota by the swab technique and the end of the venipuncture procedure was applied to the volunteer, the visual numeric scale (VNS) standard to determine the degree of pain.

Detailed Description
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Context: Research on natural products with therapeutic, analgesic or antimicrobial purpose should be encouraged to create new drugs. Acmella oleracea, typical plant of the Northern region of the country and popularly known as jambu, has aroused the interest of researchers because of its therapeutic potential. Objective: To evaluate the potential topical analgesic and antimicrobial of Acmella oleracea plant extract from the skin antisepsis in venipuncture procedures. Methods: This is a clinical, randomized, controlled trial with healthy volunteers recruited at the Clinic I of the collection of biological materials sector of the Hospital das Clinicas Samuel Libânio, in Pouso Alegre-MG. The plant extract A. oleracea manipulated with Transcutol® and 70% alcohol were used in the volunteers before the venipuncture procedure as allocation in study groups. Held collection of skin microbiota by the swab technique and the end of the venipuncture procedure was applied to the volunteer, the visual numeric scale (VNS) standard to determine the degree of pain.

Official Title
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Antiseptic and Analgesic Action Acmella Oleracea Skin: Randomized Clinical Trial

Conditions
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Phythoterapy, Venipuncture Site Numbness, Antimicrobial, Analgesic

Intervention / Treatment
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* Other: A. oleracea
* Other: 70% alcohol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy volunteers without restriction as to ethnicity educational level and social class who agreed to participate by signing the Informed Consent and Informed (IC ) Exclusion Criteria: pregnant women (due to contractile properties that can cause ) cancer patients chronic and refusal to participate in the study kidney

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acmella oleracea<br>The plant extract A. oleracea manipulated with Transcutol® were used in the volunteers 3 minutes before the venipuncture | Other: A. oleracea<br>* The plant extract A. oleracea manipulated with Transcutol® were used in the volunteers before the venipuncture procedure as allocation in study groups. Held collection of skin microbiota by the swab technique and the end of the venipuncture procedure was applied to the volunteer, the visual numeric scale (VNS) standard to determine the degree of pain.<br>* Other names: medical plants;|
| Placebo Comparator: alcohol 70%<br>70% alcohol were used in the volunteers 3 minutes before the venipuncture | Other: 70% alcohol<br>* 70% alcohol were used in the volunteers before the venipuncture procedure as allocation in study groups. Held collection of skin microbiota by the swab technique and the end of the venipuncture procedure was applied to the volunteer, the visual numeric scale (VNS) standard to determine the degree of pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The degree of pain in 15 healthy volunteers will be measured by the visual numeric scale (VNS) standard immediately after the venipuncture procedure. |  | 1 day | 
| The skin microflora in 15 healthy volunteers will be measured counted the microorganism isolated by swab technique and plated on plates containing the medium Standard Methods Agar (PCA). |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesic, Medicinal plants, Skin, Antimicrobial agents, Pain Measurement