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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator | plain mucoadhesive fast dissolving film |
|
| Treated group | Experimental | Corchorus Olitorius Buccal Films |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corchorus Olitorius Buccal fast dissolving Films | Dietary Supplement | Corchorus Olitorius Buccal fast dissolving Films |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minya university, faculty of medicin | Minya | Minya Governorate | 05673 | Egypt |
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| ID | Term |
|---|---|
| D013281 | Stomatitis, Aphthous |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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double blind masking
| plain mucoadhesive fast dissolving film | Dietary Supplement | plain mucoadhesive fast dissolving film |
|
| 6 days |