Antiseptic and Analgesic Action Acmella Oleracea Skin: Randomized Clinical Trial

NCT02792972 | Completed

• 1 other identifier: Carol2014
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Phythoterapy; Venipuncture Site Numbness; Antimicrobial; Analgesic

Keywords

Analgesic; Medicinal plants; Skin; Antimicrobial agents; Pain Measurement

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Acmella oleracea

ACTIVE COMPARATOR

The plant extract A. oleracea manipulated with Transcutol® were used in the volunteers 3 minutes before the venipuncture

Other: A. oleracea

alcohol 70%

PLACEBO COMPARATOR

70% alcohol were used in the volunteers 3 minutes before the venipuncture

Other: 70% alcohol

Interventions

A. oleracea OTHER

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.

Also known as: medical plants

Acmella oleracea

70% alcohol OTHER

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.

alcohol 70%

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy volunteers
• without restriction as to ethnicity
• educational level and social class who agreed to participate by signing the Informed Consent and Informed (IC )

You may not qualify if:

• pregnant women (due to contractile properties that can cause )
• cancer patients
• chronic and refusal to participate in the study kidney

Sponsors & Collaborators

• Ana Beatriz Alkimim Teixeira Loyola: lead

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Ana Beatriz A Teixeira Loyola, doctor

  Universidade do Vale do Sapucaí

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: June 8, 2016
• Study Start: September 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 8, 2016

Record last verified: 2016-06