Antiseptic and Analgesic Action Acmella Oleracea Skin: Randomized Clinical Trial

Analgesic Clinical Trial

Official title:

Antiseptic and Analgesic Action Acmella Oleracea Skin: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02792972
• Other study ID #: Carol2014
• Status: Completed
• Phase: N/A
• First received: May 23, 2016
• Last updated: June 7, 2016
• Start date: September 2015
• Est. completion date: September 2015

Study information

• Verified date: June 2016
• Source: Universidade do Vale do Sapucai
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Analgesic
• Antimicrobial
• Phythoterapy
• Venipuncture Site Numbness

Intervention

Other:
• A. oleracea
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.
• 70% alcohol
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ana Beatriz Alkimim Teixeira Loyola

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No