Unripe Banana Peel Powder and Lemongrass Oil in Chronic Ulcer

Chronic Ulcer Clinical Trial

Official title:

Unripe Banana Peel Powder and Lemongrass Oil in Chronic Ulcer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04963829
• Other study ID #: Banana peel
• Status: Completed
• Phase: Phase 1
• Start date: February 2, 2018
• Est. completion date: November 28, 2018

Study information

• Verified date: July 2021
• Source: Universidade do Vale do Sapucai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 28, 2018
• Est. primary completion date: November 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Ulcer
• Healing Ulcer
• Ulcer

Intervention

Biological:
• gel combined with lemongrass (Cymbopogon citratus) oil at 0.1% concentration
It is a gel that was used in chronic ulcers healing
• Collagenase ointment
Participants who were subjected to a standardized treatment (collagenase ointment)
• Gel with 10% peel powder of unripe banana
Participants who used a gel made of 10% peel powder of unripe banana (M. sapientum),

Locations

Country	Name	City	State
Brazil	Vale do Sapucaí University	Pouso Alegre	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Vale do Sapucai

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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