Unripe Banana Peel Powder and Lemongrass Oil in Chronic Ulcer

Phase 1

Completed

• Conditions: Healing Ulcer; Chronic Ulcer
• Interventions: Biological: gel combined with lemongrass (Cymbopogon citratus) oil at 0.1% concentration; Biological: Collagenase ointment; Biological: Gel with 10% peel powder of unripe banana

• Registration Number: NCT04963829
• Lead Sponsor: Universidade do Vale do Sapucai

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-02-02
• Primary Completion: 2018-11-02
• Study Completion: 2018-11-28
• Study First Submitted: 2021-06-11
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-14
• Last Update Submitted: 2021-07-14
• Study First Posted: 2021-07-15
• Last Update Posted: 2021-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group (SG)	gel combined with lemongrass (Cymbopogon citratus) oil at 0.1% concentration	Participants who used the abovementioned gel combined with lemongrass (Cymbopogon citratus) oil at 0.1% concentration.
Control Group 1 (CG1)	Collagenase ointment	Participants who were subjected to a standardized treatment (collagenase ointment was selected for this treatment),
Control Group 2 (CG2)	Gel with 10% peel powder of unripe banana	Participants who used a gel made of 10% peel powder of unripe banana (M. sapientum)

Primary Outcome Measures

Name	Time	Method
Delimitation of the wound area	3 month	To delimit the wound area, plastic and a fine-tipped pen will be used to outline the edge of the wound.

Secondary Outcome Measures

Name	Time	Method
Digitalizing drawing wounds measurements	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.

Trial Locations

Locations (1)

Vale do Sapucaí University; 🇧🇷 Pouso Alegre, Minas Gerais, Brazil