Corchorus Olitorius Buccal Films for the Treatment of Recurrent Minor Aphthous Ulcerations

Study Overview
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Brief Summary
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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.

Official Title
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The Potential of Corchorus Olitorius Seeds Buccal Films for Treatment of Recurrent Minor Aphthous Ulcerations in Human Volunteers

Conditions
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Aphthous Ulcer Recurrent

Intervention / Treatment
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* Dietary Supplement: Corchorus Olitorius Buccal fast dissolving Films
* Dietary Supplement: plain mucoadhesive fast dissolving film


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>plain mucoadhesive fast dissolving film | Dietary Supplement: plain mucoadhesive fast dissolving film<br>* plain mucoadhesive fast dissolving film<br>|
| Experimental: Treated group<br>Corchorus Olitorius Buccal Films | Dietary Supplement: Corchorus Olitorius Buccal fast dissolving Films<br>* Corchorus Olitorius Buccal fast dissolving Films<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment of ulcer | 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 | pain measured by VAS tool, 0 the least pain while 10 the highest one | 6 days | 
| Erthymia | Erthymia estimated by the dgree of redness by the investgator, the darkest indicadetes the worst one | 6 days |