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Antiseptic and Analgesic Action Acmella Oleracea Skin: Randomized Clinical Trial

Primary Purpose

Phythoterapy, Venipuncture Site Numbness, Antimicrobial

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
A. oleracea
70% alcohol
Sponsored by
Ana Beatriz Alkimim Teixeira Loyola
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Phythoterapy focused on measuring Analgesic, Medicinal plants, Skin, Antimicrobial agents, Pain Measurement

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Acmella oleracea

    alcohol 70%

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    The degree of pain in 15 healthy volunteers will be measured by the visual numeric scale (VNS) standard immediately after the venipuncture procedure.
    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    May 23, 2016
    Last Updated
    June 7, 2016
    Sponsor
    Ana Beatriz Alkimim Teixeira Loyola
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02792972
    Brief Title
    Antiseptic and Analgesic Action Acmella Oleracea Skin: Randomized Clinical Trial
    Official Title
    Antiseptic and Analgesic Action Acmella Oleracea Skin: Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ana Beatriz Alkimim Teixeira Loyola

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Phythoterapy, Venipuncture Site Numbness, Antimicrobial, Analgesic
    Keywords
    Analgesic, Medicinal plants, Skin, Antimicrobial agents, Pain Measurement

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Acmella oleracea
    Arm Type
    Active Comparator
    Arm Description
    The plant extract A. oleracea manipulated with Transcutol® were used in the volunteers 3 minutes before the venipuncture
    Arm Title
    alcohol 70%
    Arm Type
    Placebo Comparator
    Arm Description
    70% alcohol were used in the volunteers 3 minutes before the venipuncture
    Intervention Type
    Other
    Intervention Name(s)
    A. oleracea
    Other Intervention Name(s)
    medical plants
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    70% alcohol
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    The degree of pain in 15 healthy volunteers will be measured by the visual numeric scale (VNS) standard immediately after the venipuncture procedure.
    Time Frame
    1 day
    Title
    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).
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ana Beatriz A Teixeira Loyola, doctor
    Organizational Affiliation
    Universidade do Vale do Sapucaí
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Antiseptic and Analgesic Action Acmella Oleracea Skin: Randomized Clinical Trial

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