Unripe Banana Peel Powder and Lemongrass Oil in Chronic Ulcer

NCT ID: NCT04963829

Last Updated: 2021-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-02

Study Completion Date

2018-11-28

Brief Summary

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To evaluate the activity of a gel composed of 10% peel powder of unripe banana (Musa sapientum) combined with lemongrass (Cymbopogon citratus) oil, at 0.1% concentration, in patients with chronic ulcers.

Detailed Description

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Purpose: To evaluate the activity of a gel composed of 10% peel powder of unripe banana (Musa sapientum) combined with lemongrass (Cymbopogon citratus) oil, at 0.1% concentration, in patients with chronic ulcers. Methods: This is a clinical, individual, analytical, interventional, longitudinal, prospective, controlled study with convenience sampling. Three groups will be used, as follows: control group 1 (CG1) with 7 participants will be treated with collagenase, control group 2 (CG2) with 7 participants will be treated with a gel composed of 10% unripe banana peel powder, and study group (SG) with 11 patients will be treated with the abovementioned gel combined with lemongrass oil at 0.1% concentration. The ulcer areas will be analyzed once a week for 4 weeks. Afterward, wound areas will be measured and the obtained data will be subjected to statistical analysis.

Conditions

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Chronic Ulcer Healing Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Twenty-five people, regardless of gender, participated in this study. The patients were divided into 3 groups (Control 1, Control 2 and, Study Group). The Control Group 1 (CG1) consisted of seven participants who were subjected to a standardized treatment (collagenase ointment was selected for this treatment), the Control Group 2 (CG2) accounted for seven participants who used a gel made of 10% peel powder of unripe banana (M. sapientum), and the Study Group (SG) involved eleven participants who used the abovementioned gel combined with lemongrass (Cymbopogon citratus) oil at 0.1% concentration.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Study Group (SG)

Participants who used the abovementioned gel combined with lemongrass (Cymbopogon citratus) oil at 0.1% concentration.

Group Type ACTIVE_COMPARATOR

gel combined with lemongrass (Cymbopogon citratus) oil at 0.1% concentration

Intervention Type BIOLOGICAL

It is a gel that was used in chronic ulcers healing

Control Group 1 (CG1)

Participants who were subjected to a standardized treatment (collagenase ointment was selected for this treatment),

Group Type ACTIVE_COMPARATOR

Collagenase ointment

Intervention Type BIOLOGICAL

Participants who were subjected to a standardized treatment (collagenase ointment)

Control Group 2 (CG2)

Participants who used a gel made of 10% peel powder of unripe banana (M. sapientum)

Group Type ACTIVE_COMPARATOR

Gel with 10% peel powder of unripe banana

Intervention Type BIOLOGICAL

Participants who used a gel made of 10% peel powder of unripe banana (M. sapientum),

Interventions

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gel combined with lemongrass (Cymbopogon citratus) oil at 0.1% concentration

It is a gel that was used in chronic ulcers healing

Intervention Type BIOLOGICAL

Collagenase ointment

Participants who were subjected to a standardized treatment (collagenase ointment)

Intervention Type BIOLOGICAL

Gel with 10% peel powder of unripe banana

Participants who used a gel made of 10% peel powder of unripe banana (M. sapientum),

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* presence of chronic ulcers,
* 18 years of age and older

Exclusion Criteria

* Patients who had any type of allergic reaction to the study products during treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade do Vale do Sapucai

OTHER

Sponsor Role lead

Responsible Party

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Adriana Rodrigues dos Anjos Mendonça

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adriana R dos Anjos Mendonça, PhD

Role: PRINCIPAL_INVESTIGATOR

Vale do Sapucaí University

Locations

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Vale do Sapucaí University

Pouso Alegre, Minas Gerais, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Banana peel

Identifier Type: -

Identifier Source: org_study_id

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