The Potential of Corchorus Olitorius Seeds Buccal Films for Treatment of Recurrent Minor Aphthous Ulcerations in Human Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Deraya University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- treatment of ulcer
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
double blind masking
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Pregnancy and lactation (Urine hCG-positive)
- •Concurrent clinical conditions that could pose a health risk to the subjects, including serious liver, kidney, and heart dysfunctions
- •A history of an immunologic problem
Arms & Interventions
Placebo group
plain mucoadhesive fast dissolving film
Intervention: plain mucoadhesive fast dissolving film (Dietary Supplement)
Treated group
Corchorus Olitorius Buccal Films
Intervention: Corchorus Olitorius Buccal fast dissolving Films (Dietary Supplement)
Outcomes
Primary Outcomes
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
- Erthymia(6 days)
- Pain scoring(6 days)
Investigators
Soad Ali
Clinical professor
Deraya University