A Phase 1 interventional study of Corchorus Olitorius Buccal fast dissolving Films and plain mucoadhesive fast dissolving film in Aphthous Ulcer Recurrent, sponsored by Deraya University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-24.
Sponsored by Deraya University · Phase 1, Interventional, and Treatment
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.
63 studies on the registry are indexed under Stomatitis, Aphthous; 17 are open to participants now.
This study's enrollment of 20 is below the median of 41 across 54 interventional studies indexed under Stomatitis, Aphthous.
Browse Stomatitis, Aphthous studies →Deraya University is the lead sponsor of 50 studies on the registry; 6 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
plain mucoadhesive fast dissolving film
Dietary Supplement: plain mucoadhesive fast dissolving film
Corchorus Olitorius Buccal Films
Dietary Supplement: Corchorus Olitorius Buccal fast dissolving Films
Corchorus Olitorius Buccal fast dissolving Films
plain mucoadhesive fast dissolving film
treatment of ulcer
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
Pain scoring
pain measured by VAS tool, 0 the least pain while 10 the highest one
Time frame: 6 days
Erthymia
Erthymia estimated by the dgree of redness by the investgator, the darkest indicadetes the worst one
Time frame: 6 days
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Deraya University