Unripe Banana Peel Powder and Lemongrass Oil in Chronic Ulcer

Sponsor

Universidade do Vale do Sapucai (Other)

Overall Status

Completed

CT.gov ID

NCT04963829

Collaborator

(none)

Enrollment

Location

Arms

9.8

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Ulcer Healing Ulcer	Biological: gel combined with lemongrass (Cymbopogon citratus) oil at 0.1% concentration Biological: Collagenase ointment Biological: Gel with 10% peel powder of unripe banana	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Unripe Banana Peel Powder and Lemongrass Oil in Chronic Ulcer

Actual Study Start Date :

Feb 2, 2018

Actual Primary Completion Date :

Nov 2, 2018

Actual Study Completion Date :

Nov 28, 2018

Arms and Interventions

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),

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),

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vale do Sapucaí University	Pouso Alegre	Minas Gerais	Brazil	37550-000

Sponsors and Collaborators

Universidade do Vale do Sapucai

Investigators

Principal Investigator: Adriana R dos Anjos Mendonça, PhD, Vale do Sapucaí University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Adriana Rodrigues dos Anjos Mendonça, Principal Investigator, Universidade do Vale do Sapucai

ClinicalTrials.gov Identifier:

NCT04963829

Other Study ID Numbers:

Banana peel

First Posted:

Jul 15, 2021

Last Update Posted:

Jul 15, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Adriana Rodrigues dos Anjos Mendonça, Principal Investigator, Universidade do Vale do Sapucai

Additional relevant MeSH terms:

Ulcer

Study Results

No Results Posted as of Jul 15, 2021