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

October 20, 2022 updated by: Soad Ali, Deraya University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • المنيا
      • Minya, المنيا, Egypt, 05673
        • Minya university, faculty of medicin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
plain mucoadhesive fast dissolving film
Dietary supplement: plain mucoadhesive fast dissolving film
plain mucoadhesive fast dissolving film
Experimental: Treated group
Corchorus Olitorius Buccal Films
Dietary supplement: Corchorus Olitorius Buccal fast dissolving Films
Corchorus Olitorius Buccal fast dissolving Films

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deraya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2022

Primary Completion (Actual)

June 18, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

May 22, 2022

First Submitted That Met QC Criteria

May 25, 2022

First Posted (Actual)

May 26, 2022

Study Record Updates

Last Update Posted (Actual)

October 24, 2022

Last Update Submitted That Met QC Criteria

October 20, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Orafilms

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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