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CompletedNCT02792972Updated Jun 8, 2016

Antiseptic and Analgesic Action Acmella Oleracea Skin: Randomized Clinical Trial

An interventional study of A. oleracea and 70% alcohol in Phythoterapy, Venipuncture Site Numbness and Antimicrobial, sponsored by Ana Beatriz Alkimim Teixeira Loyola. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-06-08.

Sponsored by Ana Beatriz Alkimim Teixeira Loyola · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Phythoterapy
  • Venipuncture Site Numbness
  • Antimicrobial
  • Analgesic

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Keywords

  • Analgesic
  • Medicinal plants
  • Skin
  • Antimicrobial agents
  • Pain Measurement
03

In context

Hypesthesia

47 studies on the registry are indexed under Hypesthesia; 12 are open to participants now.

This study's enrollment of 60 is above the median of 50 across 43 interventional studies indexed under Hypesthesia.

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Lead sponsor

This is the only study on the registry with Ana Beatriz Alkimim Teixeira Loyola as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • pregnant women (due to contractile properties that can cause )
  • cancer patients
  • chronic and refusal to participate in the study kidney
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Acmella oleracea

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

    Other: A. oleracea

  • Placebo comparator
    alcohol 70%

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

    Other: 70% alcohol

Interventions

  • OtherA. 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.

    Also known as: medical plants

  • Other70% 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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2015, a primary completion of Sep 2015 and a completion of Sep 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 23, 2016
First posted
Jun 8, 2016
Start
Sep 2015
Primary completionActual
Sep 2015
CompletionActual
Sep 2015
Last update
Jun 8, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02792972
Lead sponsor
Ana Beatriz Alkimim Teixeira Loyola
Responsible party
Ana Beatriz Alkimim Teixeira Loyola (MD, Universidade do Vale do Sapucai) — Sponsor-investigator
First posted
Jun 8, 2016
Start date
Sep 2015
Primary completion
Sep 2015
Completion
Sep 2015
Last update
Jun 8, 2016

Study contacts

Ana Beatriz A Teixeira Loyola, doctor
study director · Universidade do Vale do Sapucaí
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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