Unripe Banana Peel Powder and Lemongrass Oil in Chronic Ulcer

Study Overview
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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.

Official Title
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Unripe Banana Peel Powder and Lemongrass Oil in Chronic Ulcer

Conditions
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Chronic Ulcer, Healing Ulcer

Intervention / Treatment
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* Biological: gel combined with lemongrass (Cymbopogon citratus) oil at 0.1% concentration
* Biological: Collagenase ointment
* Biological: Gel with 10% peel powder of unripe banana


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study Group (SG)<br>Participants who used the abovementioned gel combined with lemongrass (Cymbopogon citratus) oil at 0.1% concentration. | Biological: gel combined with lemongrass (Cymbopogon citratus) oil at 0.1% concentration<br>* It is a gel that was used in chronic ulcers healing<br>|
| Active Comparator: Control Group 1 (CG1)<br>Participants who were subjected to a standardized treatment (collagenase ointment was selected for this treatment), | Biological: Collagenase ointment<br>* Participants who were subjected to a standardized treatment (collagenase ointment)<br>|
| Active Comparator: Control Group 2 (CG2)<br>Participants who used a gel made of 10% peel powder of unripe banana (M. sapientum) | Biological: Gel with 10% peel powder of unripe banana<br>* Participants who used a gel made of 10% peel powder of unripe banana (M. sapientum),<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delimitation of the wound area | To delimit the wound area, plastic and a fine-tipped pen will be used to outline the edge of the wound. | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Digitalizing drawing wounds measurements | 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healing Ulcer, Chronic Ulcer, Musa sapientum, Lemongrass