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Unripe Banana Peel Powder and Lemongrass Oil in Chronic Ulcer

Primary Purpose

Chronic Ulcer, Healing Ulcer

Status

Completed

Phase

Phase 1

Locations

Brazil

Study Type

Interventional

Intervention

gel combined with lemongrass (Cymbopogon citratus) oil at 0.1% concentration

Collagenase ointment

Gel with 10% peel powder of unripe banana

About this trial

This is an interventional treatment trial for Chronic Ulcer focused on measuring Healing Ulcer, Chronic Ulcer, Musa sapientum, Lemongrass

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Vale do Sapucaí University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Study Group (SG)

Control Group 1 (CG1)

Control Group 2 (CG2)

Arm Description

Participants who used the abovementioned gel combined with lemongrass (Cymbopogon citratus) oil at 0.1% concentration.

Participants who were subjected to a standardized treatment (collagenase ointment was selected for this treatment),

Participants who used a gel made of 10% peel powder of unripe banana (M. sapientum)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04963829

First Posted

June 11, 2021

Last Updated

July 14, 2021

Sponsor

Universidade do Vale do Sapucai

1. Study Identification

Unique Protocol Identification Number

NCT04963829

Brief Title

Unripe Banana Peel Powder and Lemongrass Oil in Chronic Ulcer

Official Title

Unripe Banana Peel Powder and Lemongrass Oil in Chronic Ulcer

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

February 2, 2018 (Actual)

Primary Completion Date

November 2, 2018 (Actual)

Study Completion Date

November 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidade do Vale do Sapucai

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Ulcer, Healing Ulcer

Keywords

Healing Ulcer, Chronic Ulcer, Musa sapientum, Lemongrass

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

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.

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Group (SG)

Arm Type

Active Comparator

Arm Description

Participants who used the abovementioned gel combined with lemongrass (Cymbopogon citratus) oil at 0.1% concentration.

Arm Title

Control Group 1 (CG1)

Arm Type

Active Comparator

Arm Description

Participants who were subjected to a standardized treatment (collagenase ointment was selected for this treatment),

Arm Title

Control Group 2 (CG2)

Arm Type

Active Comparator

Arm Description

Participants who used a gel made of 10% peel powder of unripe banana (M. sapientum)

Intervention Type

Biological

Intervention Name(s)

gel combined with lemongrass (Cymbopogon citratus) oil at 0.1% concentration

Intervention Description

It is a gel that was used in chronic ulcers healing

Intervention Type

Biological

Intervention Name(s)

Collagenase ointment

Intervention Description

Participants who were subjected to a standardized treatment (collagenase ointment)

Intervention Type

Biological

Intervention Name(s)

Gel with 10% peel powder of unripe banana

Intervention Description

Participants who used a gel made of 10% peel powder of unripe banana (M. sapientum),

Primary Outcome Measure Information:

Title

Delimitation of the wound area

Description

To delimit the wound area, plastic and a fine-tipped pen will be used to outline the edge of the wound.

Time Frame

3 month

Secondary Outcome Measure Information:

Title

Digitalizing drawing wounds measurements

Description

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adriana R dos Anjos Mendonça, PhD

Organizational Affiliation

Vale do Sapucaí University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vale do Sapucaí University

City

Pouso Alegre

State/Province

Minas Gerais

ZIP/Postal Code

37550-000

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Unripe Banana Peel Powder and Lemongrass Oil in Chronic Ulcer

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