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Completed

NCT Number: NCT04963829

Unripe Banana Peel Powder and Lemongrass Oil in Chronic Ulcer

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.

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Key information

Conditions

Chronic Ulcer Healing Ulcer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vale do Sapucaí University

Pouso Alegre, Minas Gerais, 37550-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Biological

It is a gel that was used in chronic ulcers healing

Collagenase ointment

Biological

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

Gel with 10% peel powder of unripe banana

Biological

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

Primary outcomes

  1. Delimitation of the wound area

    Time frame: 3 month

    To delimit the wound area, plastic and a fine-tipped pen will be used to outline the edge of the wound.

Secondary outcomes

  1. Digitalizing drawing wounds measurements

    Time frame: 3 months

    All collected measurements (drawings) were scanned and saved in JPEG format and the areas were calculated using the ImageJ® software13.

    The ImageJ® was set to measure the area in centimeters, with a pixel of 118.67, establishing a fixed value. The areas were calculated individually in the software and the values were saved in an Excel spreadsheet.

Sponsors and collaborators

Lead sponsor

Universidade do Vale do Sapucai

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 15, 2021
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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