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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group (SG) | Active Comparator | Participants who used the abovementioned gel combined with lemongrass (Cymbopogon citratus) oil at 0.1% concentration. |
|
| Control Group 1 (CG1) | Active Comparator | Participants who were subjected to a standardized treatment (collagenase ointment was selected for this treatment), |
|
| Control Group 2 (CG2) | Active Comparator | Participants who used a gel made of 10% peel powder of unripe banana (M. sapientum) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gel combined with lemongrass (Cymbopogon citratus) oil at 0.1% concentration | Biological | It is a gel that was used in chronic ulcers healing |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adriana R dos Anjos Mendonça, PhD | Vale do Sapucaà University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vale do Sapucaà University | Pouso Alegre | Minas Gerais | 37550-000 | Brazil |
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| ID | Term |
|---|---|
| D017364 | Collagenases |
| D005782 | Gels |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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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.
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| 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), |
|
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |