Corchorus Olitorius Buccal Films for the Treatment of Recurrent Minor Aphthous Ulcerations
October 20, 2022 updated by: Soad Ali, Deraya University
The Potential of Corchorus Olitorius Seeds Buccal Films for Treatment of Recurrent Minor Aphthous Ulcerations in Human Volunteers
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
المنيا
-
Minya, المنيا, Egypt, 05673
- Minya university, faculty of medicin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo group
plain mucoadhesive fast dissolving film
|
plain mucoadhesive fast dissolving film
|
|
Experimental: Treated group
Corchorus Olitorius Buccal Films
|
Corchorus Olitorius Buccal fast dissolving Films
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
treatment of ulcer
Time Frame: 6 days
|
ulcer size by the investigator, the diameter measured as the distance between two oppisit points of the wight area of ulcer
|
6 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain scoring
Time Frame: 6 days
|
pain measured by VAS tool, 0 the least pain while 10 the highest one
|
6 days
|
|
Erthymia
Time Frame: 6 days
|
Erthymia estimated by the dgree of redness by the investgator, the darkest indicadetes the worst one
|
6 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 10, 2022
Primary Completion (Actual)
June 18, 2022
Study Completion (Actual)
July 1, 2022
Study Registration Dates
First Submitted
May 22, 2022
First Submitted That Met QC Criteria
May 25, 2022
First Posted (Actual)
May 26, 2022
Study Record Updates
Last Update Posted (Actual)
October 24, 2022
Last Update Submitted That Met QC Criteria
October 20, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Orafilms
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.