Back to resultsCorchorus Olitorius Buccal Films for the Treatment of Recurrent Minor Aphthous Ulcerations
Primary Purpose
Aphthous Ulcer Recurrent
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Corchorus Olitorius Buccal fast dissolving Films
plain mucoadhesive fast dissolving film
Sponsored by
About this trial
This is an interventional treatment trial for Aphthous Ulcer Recurrent
Eligibility Criteria
Inclusion Criteria:
- Males and females aged 18-65 years old
- Willingness to participate and sign the informed consent forms
- Presenting with 1 to 5 aphthous ulcers (less than 72 hours' duration) with a size no greater than 5 mm in diameter
- An expectation that their ulcers normally take 5 or more days to resolve without treatment
Exclusion Criteria:
- A known history of serious drug hypersensitivities 2. Pregnancy and lactation (Urine hCG-positive) 3. Concurrent clinical conditions that could pose a health risk to the subjects, including serious liver, kidney, and heart dysfunctions 4. A history of an immunologic problem
Sites / Locations
- Minya university, faculty of medicin
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo group
Treated group
Arm Description
plain mucoadhesive fast dissolving film
Corchorus Olitorius Buccal Films
Outcomes
Primary Outcome Measures
treatment of ulcer
ulcer size by the investigator, the diameter measured as the distance between two oppisit points of the wight area of ulcer
Secondary Outcome Measures
Pain scoring
pain measured by VAS tool, 0 the least pain while 10 the highest one
Erthymia
Erthymia estimated by the dgree of redness by the investgator, the darkest indicadetes the worst one
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05392842
Brief Title
Corchorus Olitorius Buccal Films for the Treatment of Recurrent Minor Aphthous Ulcerations
Official Title
The Potential of Corchorus Olitorius Seeds Buccal Films for Treatment of Recurrent Minor Aphthous Ulcerations in Human Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 10, 2022 (Actual)
Primary Completion Date
June 18, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Deraya University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A methanol extract of Corchorus olitorius edible plant was perpared for extration of glycosideal compounds. the extract was tested for its efficacy as antiinflammatory and analgesic activity invitro and approved by the biomarkers. a fast dissolvinf mucoadhesive film was prepared by a certain amounts of highly safe polymers for a pilote study on human for treament of Aphthous Ulcerations. two groups of study, placebo and intrvention will be recurited and followed for pain, erthymia and size of ulcers for 6 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphthous Ulcer Recurrent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
double blind masking
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
plain mucoadhesive fast dissolving film
Arm Title
Treated group
Arm Type
Experimental
Arm Description
Corchorus Olitorius Buccal Films
Intervention Type
Dietary Supplement
Intervention Name(s)
Corchorus Olitorius Buccal fast dissolving Films
Intervention Description
Corchorus Olitorius Buccal fast dissolving Films
Intervention Type
Dietary Supplement
Intervention Name(s)
plain mucoadhesive fast dissolving film
Intervention Description
plain mucoadhesive fast dissolving film
Primary Outcome Measure Information:
Title
treatment of ulcer
Description
ulcer size by the investigator, the diameter measured as the distance between two oppisit points of the wight area of ulcer
Time Frame
6 days
Secondary Outcome Measure Information:
Title
Pain scoring
Description
pain measured by VAS tool, 0 the least pain while 10 the highest one
Time Frame
6 days
Title
Erthymia
Description
Erthymia estimated by the dgree of redness by the investgator, the darkest indicadetes the worst one
Time Frame
6 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males and females aged 18-65 years old
Willingness to participate and sign the informed consent forms
Presenting with 1 to 5 aphthous ulcers (less than 72 hours' duration) with a size no greater than 5 mm in diameter
An expectation that their ulcers normally take 5 or more days to resolve without treatment
Exclusion Criteria:
A known history of serious drug hypersensitivities 2. Pregnancy and lactation (Urine hCG-positive) 3. Concurrent clinical conditions that could pose a health risk to the subjects, including serious liver, kidney, and heart dysfunctions 4. A history of an immunologic problem
Facility Information:
Facility Name
Minya university, faculty of medicin
City
Minya
State/Province
المنيا
ZIP/Postal Code
05673
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Corchorus Olitorius Buccal Films for the Treatment of Recurrent Minor Aphthous Ulcerations
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