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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05392842

Enrollment

Registered

2022-05-26

Start date

2022-04-10

Completion date

2022-07-01

Last updated

2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphthous Ulcer Recurrent

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTCorchorus Olitorius Buccal fast dissolving Films

Corchorus Olitorius Buccal fast dissolving Films

DIETARY_SUPPLEMENTplain mucoadhesive fast dissolving film

plain mucoadhesive fast dissolving film

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

double blind masking

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

1. Males and females aged 18-65 years old 2. Willingness to participate and sign the informed consent forms 3. Presenting with 1 to 5 aphthous ulcers (less than 72 hours' duration) with a size no greater than 5 mm in diameter 4. 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

Design outcomes

Primary

Measure	Time frame	Description
treatment of ulcer	6 days	ulcer size by the investigator, the diameter measured as the distance between two oppisit points of the wight area of ulcer

Secondary

Measure	Time frame	Description
Pain scoring	6 days	pain measured by VAS tool, 0 the least pain while 10 the highest one
Erthymia	6 days	Erthymia estimated by the dgree of redness by the investgator, the darkest indicadetes the worst one

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026