Aphthous Ulcer RecurrentPhase 1NCT05392842
Corchorus Olitorius Buccal Films for the Treatment of Recurrent Minor Aphthous Ulcerations
A Phase 1 study testing Corchorus Olitorius Buccal fast dissolving Films and plain mucoadhesive fast dissolving film in people with Aphthous Ulcer Recurrent, run by Deraya University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Aphthous Ulcer Recurrent
- What is being tested?
- Corchorus Olitorius Buccal fast dissolving Films and plain mucoadhesive fast dissolving film
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2022to 1 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Minya university, faculty of medicin
Minya, Minya Governorate, 05673
About this study
Official title: 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.
- Conditions
- Aphthous Ulcer Recurrent
- Being tested
- Corchorus Olitorius Buccal fast dissolving Films, plain mucoadhesive fast dissolving film
- Medical subject headings
- Stomatitis, Aphthous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corchorus Olitorius Buccal fast dissolving FilmsDietary supplement
Corchorus Olitorius Buccal fast dissolving Films
plain mucoadhesive fast dissolving filmDietary supplement
plain mucoadhesive fast dissolving film
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | plain mucoadhesive fast dissolving film Receives: Dietary Supplement: plain mucoadhesive fast dissolving film |
| Treated group | Experimental | Corchorus Olitorius Buccal Films Receives: Dietary Supplement: Corchorus Olitorius Buccal fast dissolving Films |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment of ulcer
ulcer size by the investigator, the diameter measured as the distance between two oppisit points of the wight area of ulcer
Measured: 6 days
Secondary outcomes (2)
Pain scoring
pain measured by VAS tool, 0 the least pain while 10 the highest one
Measured: 6 days
Erthymia
Erthymia estimated by the dgree of redness by the investgator, the darkest indicadetes the worst one
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start10 Apr 2022
- Primary completion18 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphthous Ulcer RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soad Ali, Deraya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392842
- Sponsor's protocol ID
- Orafilms
- Status last verified
- Oct 2022
- First submitted
- 22 May 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential of Corchorus Olitorius Seeds Buccal Films for Treatment of Recurrent Minor Aphthous Ulcerations in Human Volunteers
- ClinicalTrials.gov ID
- NCT05392842
- Acronym / sponsor ID
- Orafilms
- Conditions
- Aphthous Ulcer Recurrent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Deraya UniversityUniversity, hospital or other
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 18 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Dietary Supplement: plain mucoadhesive fast dissolving filmplain mucoadhesive fast dissolving film |
| Treated group | Experimental | Dietary Supplement: Corchorus Olitorius Buccal fast dissolving FilmsCorchorus Olitorius Buccal Films |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corchorus Olitorius Buccal fast dissolving FilmsCorchorus Olitorius Buccal fast dissolving Films | Dietary supplement | Treated group |
| plain mucoadhesive fast dissolving filmplain mucoadhesive fast dissolving film | Dietary supplement | Placebo group |
Primary outcome
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
2 secondary outcomes
Pain scoring
Time frame: 6 days
Erthymia
Time frame: 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Corchorus Olitorius Buccal fast dissolving Films and plain mucoadhesive fast dissolving film in people with Aphthous Ulcer Recurrent, run by Deraya University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment of ulcer (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.