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

Phase 1

Completed

• Conditions: Aphthous Ulcer Recurrent
• Interventions: Dietary Supplement: plain mucoadhesive fast dissolving film; Dietary Supplement: Corchorus Olitorius Buccal fast dissolving Films

• Registration Number: NCT05392842
• Lead Sponsor: Deraya University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-10
• Study First Submitted: 2022-05-22
• Study First Submitted QC: 2022-05-25
• Study First Posted: 2022-05-26
• Primary Completion: 2022-06-18
• Study Completion: 2022-07-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-20
• Last Update Posted: 2022-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	plain mucoadhesive fast dissolving film	plain mucoadhesive fast dissolving film
Treated group	Corchorus Olitorius Buccal fast dissolving Films	Corchorus Olitorius Buccal Films

Primary Outcome Measures

Name	Time	Method
treatment of ulcer	6 days	ulcer size by the investigator, the diameter measured as the distance between two oppisit points of the wight area of ulcer

Secondary Outcome Measures

Name	Time	Method
Erthymia	6 days	Erthymia estimated by the dgree of redness by the investgator, the darkest indicadetes the worst one
Pain scoring	6 days	pain measured by VAS tool, 0 the least pain while 10 the highest one

Trial Locations

Locations (1)

Minya university, faculty of medicin; 🇪🇬 Minya, المنيا, Egypt