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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Pouso Alegre, Minas Gerais, Brazil, 37550-000
      • Vale do Sapucaí University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Study Group (SG); 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; It is a gel that was used in chronic ulcers healing
ACTIVE_COMPARATOR: Control Group 1 (CG1); Participants who were subjected to a standardized treatment (collagenase ointment was selected for this treatment),	Biological: Collagenase ointment; Participants who were subjected to a standardized treatment (collagenase ointment)
ACTIVE_COMPARATOR: Control Group 2 (CG2); Participants who used a gel made of 10% peel powder of unripe banana (M. sapientum)	Biological: Gel with 10% peel powder of unripe banana; Participants who used a gel made of 10% peel powder of unripe banana (M. sapientum),

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidade do Vale do Sapucai

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 2, 2018
• Primary Completion (ACTUAL): November 2, 2018
• Study Completion (ACTUAL): November 28, 2018

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (ACTUAL): July 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 15, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Healing Ulcer; Chronic Ulcer; Musa sapientum; Lemongrass
• Additional Relevant MeSH Terms: Pathologic Processes; Ulcer
• Other Study ID Numbers: Banana peel

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No