A Phase 2 interventional study of 35% Topical Bromelain in Orabase and 50% Topical Bromelain in Orabase in Recurrent Aphthous Stomatitis, sponsored by Cairo University. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by Cairo University · Phase 2, Interventional, and Treatment
Bromelain, a natural product, exhibits anti-inflammatory, immunomodulatory, and wound-healing properties. However, its efficacy in treating oral mucosal ulcers remains unexplored. This study aims to evaluate the effect of bromelain as a safe alternate for management of RAS.
63 studies on the registry are indexed under Stomatitis, Aphthous; 17 are open to participants now.
This study's planned enrollment of 63 is above the median of 41 across 54 interventional studies indexed under Stomatitis, Aphthous.
Browse Stomatitis, Aphthous studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will receive 35% bromelain gel incorporated into an orabase adhesive medium.
Dietary Supplement: 35% Topical Bromelain in Orabase
Participants assigned to this group will be treated with 50% bromelain gel formulated in orabase.
Dietary Supplement: 50% Topical Bromelain in Orabase
This group will receive the standard treatment of 0.1% triamcinolone acetonide in orabase, commonly used for managing Recurrent Aphthous Stomatitis.
Drug: 0.1% Topical Triamcinolone Acetonide in Orabase
Bromelain is a natural proteolytic enzyme derived from pineapple, recognized for its broad range of pharmacological properties. It exhibits significant anti-inflammatory effects by reducing edema. In addition to its anti-inflammatory activity, bromelain possesses antioxidant and analgesic properties.
Bromelain is a natural proteolytic enzyme derived from pineapple, recognized for its broad range of pharmacological properties. It exhibits significant anti-inflammatory effects by reducing edema. In addition to its anti-inflammatory activity, bromelain possesses antioxidant and analgesic properties.
Triamcinolone acetonide in orabase, a corticosteroid-based standard treatment for Recurrent Aphthous Stomatitis (RAS), is used for its strong anti-inflammatory and immunosuppressive effects. In this study, it serves as the conventional treatment against the novel therapy
Pain associated with ulcers
Pain reduction will be measured using a visual analog scale (VAS). VAS is a self-reported pain scores ranging from 0 to 10
Time frame: Recorded at baseline, day 2, day 4 and day 7
Reduction in ulcer size
The reduction in ulcer size will be assessed using periodontal probe to measure dimensions in millimeters (mm)
Time frame: Recorded at baseline, day 2, day 4 and day 7
Number of oral ulcers
Time frame: Recorded at baseline, day 2, day 4 and day 7
Healing time of oral ulcer
The time to complete healing will be determined by the number of days until the ulcer is no longer visible upon clinical examination
Time frame: Recorded at baseline, day 2, day 4 and day 7
Oral ulcer activity index
Oral ulcer activity index will be measured by Composite index (CI). CI score (0-10) is calculated by summing of subscale scores of oral ulcer activity (0 vs 1), oral ulcer-related pain status evaluated by categorized VAS (0-5) and the mean global functional disability score evaluated by 5-point Likert-type scale (0-4)
Time frame: Recorded at baseline, day 2, day 4 and day 7
No study locations are listed for this record.
Start is estimated for Jun 2025; primary completion for May 2026, 11 months later.
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