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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-10

Study Completion Date

2022-07-01

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.

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Detailed Description

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Conditions

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Aphthous Ulcer Recurrent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

double blind masking

Study Groups

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Placebo group

plain mucoadhesive fast dissolving film

Group Type PLACEBO_COMPARATOR

plain mucoadhesive fast dissolving film

Intervention Type DIETARY_SUPPLEMENT

plain mucoadhesive fast dissolving film

Treated group

Corchorus Olitorius Buccal Films

Group Type EXPERIMENTAL

Corchorus Olitorius Buccal fast dissolving Films

Intervention Type DIETARY_SUPPLEMENT

Corchorus Olitorius Buccal fast dissolving Films

Interventions

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Corchorus Olitorius Buccal fast dissolving Films

Intervention Type DIETARY_SUPPLEMENT

plain mucoadhesive fast dissolving film

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes