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

Deraya University

Status and phase: Completed; Phase 1

Conditions: Aphthous Ulcer Recurrent

Treatments: Dietary Supplement: plain mucoadhesive fast dissolving film; Dietary Supplement: Corchorus Olitorius Buccal fast dissolving Films

Study type: Interventional

Funder types: Other

Identifiers

NCT05392842

Orafilms

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

20 participants in 2 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

plain mucoadhesive fast dissolving film

Treatment:

Dietary Supplement: plain mucoadhesive fast dissolving film

Treated group

Experimental group

Description:

Corchorus Olitorius Buccal Films

Treatment:

Dietary Supplement: Corchorus Olitorius Buccal fast dissolving Films