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The effect of Bromelain on recurrent aphthous stomatitis

A comparative study on the effect of oral bromelain capsules versus placebo on pain intensity and healing time in patients with recurrent aphthous stomatitis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250113064371N1
Enrollment
20
Registered
2025-11-14
Start date
2025-12-22
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Aphthous Stomatitis. Recurrent oral aphthae

Interventions

Intervention 1: Intervention group: Patients suffering from minor aphthous oral ulcers will be instructed to take one capsule every 12 hours (two capsules per day) on an empty stomach until their ora

Sponsors

Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The presence of minor aphthous ulcers in the oral mucosa of the lips or cheeks for a minimum of four episodes per year

Exclusion criteria

Exclusion criteria: Systemic disease causing oral ulcers History of receiving chemotherapy, immunosuppressants, or corticosteroids within the past year Patients with other mucosal lesions Pregnant and breastfeeding women Patients undergoing treatment with anticoagulant medications Patients whose normal healing of aphthous ulcers typically occurs in less than 5 days.

Design outcomes

Primary

MeasureTime frame
Wound area. Timepoint: All patients in both periods are examined by a specialist in oral and dental diseases on the first, third, fifth, and seventh days. If healing of the lesions occurs at any time prior to these examinations, subsequent assessments will not be conducted. In the absence of healing by the seventh day, the use of the capsule or placebo will continue, and the patient will be re-examined on the tenth day. Method of measurement: Measurement of the wound diameter in patients will be conducted using an Iwanson gauge with an accuracy of one-tenth of a millimeter, recording both the maximum and minimum diameters. Subsequently, the area of the wound will be calculated using a mathematical formula based on the shape of the wound (circular or elliptical).;Pain. Timepoint: All patients in both periods are examined by a specialist in oral and dental diseases on the first, third, fifth, and seventh days. If healing of the lesions occurs at any time prior to these examinations, subsequent assessments will not be conducted. In the absence of healing by the seventh day, the use of the capsule or placebo will continue, and the patient will be re-examined on the tenth day. Method of measurement: Pain will be evaluated using the VAS (Visual Analog Scale) as a numerical measure from 0 to 10. For the patient, the number zero will be described as a state of no pain, while the number ten will represent the most severe pain experienced. In order to standardize the pain-inducing stimulus among patients, unsweetened orange juice (single-use) will be utilized.;Duration of Recovery. Timepoint: All patients in both periods are examined by a specialist in oral and dental diseases on the first, third, fifth, and seventh days. If healing of the lesions occurs at any time prior to these examinations, subsequent assessments will not be conducted. In the absence of healing by the seventh day, the use of the capsule or placebo will continue, and the patient will be re-examined on the

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSobhan Cholaki

Babol University of Medical Sciences

cholaki.dent@gmail.com+98 11 3219 9592

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026