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NCT05392842

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

Completed Phase 1 Last updated 24 October 2022
What this trial tests

Phase 1 trial testing Corchorus Olitorius Buccal fast dissolving Films in Aphthous Ulcer Recurrent in 20 participants. Completed in 1 July 2022.

Timeline
10 April 2022
Primary endpoint
18 June 2022
1 July 2022

Quick facts

Lead sponsorDeraya University
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment20
Start date10 April 2022
Primary completion18 June 2022
Estimated completion1 July 2022
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Deraya University

Who can join

Adults 18 to 60, any sex, with Aphthous Ulcer Recurrent. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The Potential of <i>Corchorus olitorius</i> Seeds Buccal Films for Treatment of Recurrent Minor Aphthous Ulcerations in Human Volunteers.
    Shady NH, Altemani AH, Altemani FH, Maher SA, et al · · 2022 · cited 9× · PMID 36296628 · DOI 10.3390/molecules27207020

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