Antiseptic and Analgesic Action Acmella Oleracea Skin: Randomized Clinical Trial

Not Applicable

Completed

• Conditions: Antimicrobial; Phythoterapy; Venipuncture Site Numbness; Analgesic
• Interventions: Other: A. oleracea; Other: 70% alcohol

• Registration Number: NCT02792972
• Lead Sponsor: Ana Beatriz Alkimim Teixeira Loyola

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Study First Submitted: 2016-05-23
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-07
• Last Update Submitted: 2016-06-07
• Study First Posted: 2016-06-08
• Last Update Posted: 2016-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acmella oleracea	A. oleracea	The plant extract A. oleracea manipulated with Transcutol® were used in the volunteers 3 minutes before the venipuncture
alcohol 70%	70% alcohol	70% alcohol were used in the volunteers 3 minutes before the venipuncture

Primary Outcome Measures

Name	Time	Method
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