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Completed

NCT Number: NCT05392842

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

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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Key information

Conditions

Aphthous Ulcer Recurrent Mouth Diseases Stomatitis Stomatitis, Aphthous Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Minya university, faculty of medicin

Minya, Minya Governorate, 05673, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Corchorus Olitorius Buccal fast dissolving Films

Dietary Supplement

Corchorus Olitorius Buccal fast dissolving Films

plain mucoadhesive fast dissolving film

Dietary Supplement

plain mucoadhesive fast dissolving film

Primary outcomes

  1. treatment of ulcer

    Time frame: 6 days

    ulcer size by the investigator, the diameter measured as the distance between two oppisit points of the wight area of ulcer

Secondary outcomes

  1. Pain scoring

    Time frame: 6 days

    pain measured by VAS tool, 0 the least pain while 10 the highest one

  2. Erthymia

    Time frame: 6 days

    Erthymia estimated by the dgree of redness by the investgator, the darkest indicadetes the worst one

Sponsors and collaborators

Lead sponsor

Deraya University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 26, 2022
Registry last updated
Oct 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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