Unripe Banana Peel Powder and Lemongrass Oil in Chronic Ulcer

NCT04963829 | Completed Phase 1 DMC

• 1 other identifier: Banana peel
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Ulcer; Healing Ulcer

Keywords

Healing Ulcer; Chronic Ulcer; Musa sapientum; Lemongrass

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Digitalizing drawing wounds measurements

  3 months

Study Arms (3)

Study Group (SG)

ACTIVE COMPARATOR

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

Control Group 1 (CG1)

ACTIVE COMPARATOR

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

Biological: Collagenase ointment

Control Group 2 (CG2)

ACTIVE COMPARATOR

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

Biological: Gel with 10% peel powder of unripe banana

Interventions

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

It is a gel that was used in chronic ulcers healing

Study Group (SG)

Collagenase ointment BIOLOGICAL

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

Control Group 1 (CG1)

Gel with 10% peel powder of unripe banana BIOLOGICAL

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

Control Group 2 (CG2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• presence of chronic ulcers,
• years of age and older

You may not qualify if:

• Patients who had any type of allergic reaction to the study products during treatment

Sponsors & Collaborators

• Universidade do Vale do Sapucai: lead

Study Sites (1)

Vale do Sapucaí University

Pouso Alegre, Minas Gerais, 37550-000, Brazil

Location

MeSH Terms

Interventions

Collagenases; Gels

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Adriana R dos Anjos Mendonça, PhD

  Vale do Sapucaí University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: July 15, 2021
• Study Start: February 2, 2018
• Primary Completion: November 2, 2018
• Study Completion: November 28, 2018
• Last Updated: July 15, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)