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
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
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
NCT ID
NCT02792972
First Posted
May 23, 2016
Last Updated
June 7, 2016
Sponsor
Ana Beatriz Alkimim Teixeira Loyola
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
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Antiseptic and Analgesic Action Acmella Oleracea Skin: Randomized Clinical Trial
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