Clinical trial NCT06839313: Effect of St. John's Wort in the Treatment of Recurrent Aphthous Stomatitis
Official title: Comparative Evaluation of the Effect of Hypericum Perforatum on Pain Level in the Treatment of Recurrent Aphthous Stomatitis:A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stomatitis, Aphthous
Keywords: Rehabilitation
Hypericum perforatum
Pain
Hyaluronic Acid
Corticosteroid
Lead sponsor: Batman University
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients were divided into three groups
Primary purpose: TREATMENT

Brief summary: The aim of the treatment of Recurrent Aphthous Stomatitis (RAS) is to accelerate the healing of ulcers by reducing pain and inflammation, thus enabling patients to perform their oral functions comfortably. It has been said many times in the literature that St. John's wort is very effective in wound healing.In this study, the evaluation of the therapeutic effects of St. John's wort extract on the clinical symptoms and ulcer healing rate in patients with Recurrent Aphthous Stomatitis (RAS), a condition with no definitive treatment, was aimed.

Detailed description: he etiology of Recurrent Aphthous Stomatitis (RAS) remains incompletely understood. Various therapeutic approaches, including topical and systemic agents, have been employed to alleviate pain, reduce ulcer dimensions, and prolong disease-free intervals. First-line management of RAS typically involves topical pharmacological agents. Among these, triamcinolone acetonide (TA), a corticosteroid derivative, is extensively utilized in the treatment of moderate-to-severe RAS due to its anti-inflammatory properties.

Hyaluronic acid (HA) gel, a more recent therapeutic option, has been demonstrated to effectively mitigate pain associated with RAS without inducing systemic or local adverse effects. Furthermore, Hypericum perforatum (St. John's Wort) has gained significant attention in the scientific community owing to its pharmacological properties, including antiviral, antibacterial, antioxidant, and anti-inflammatory effects. Studies evaluating the topical application of Hypericum perforatum extract in wound healing have indicated that it significantly enhances tissue repair and regeneration.

This study aims to compare the efficacy of triamcinolone acetonide, hyaluronic acid gel, and Hypericum perforatum extract in pain management and ulcer size reduction in patients with RAS.

Eligibility criteria: Inclusion Criteria:

1. 18 years and over
2. Having a history of RAS for at least 2 years
3. Having one in an easily accessible area in the mouth
4. RAS has not exceeded a period of 48 hours

Exclusion Criteria:

1. Having any allergic history to these substances to be applied
2. During pregnancy and lactation
3. Use of steroids, vitamins, antibiotics, antihistamines, oral retinoids or immune system regulating agents for ulcer treatment within 3 months
4. The patient has a history of systemic disease

Primary outcomes:
measure: Pain level
timeFrame: Pain levels will be measured on days 0, 3, 5 and 7.
Secondary outcomes:
measure: Size of ulcer
timeFrame: Size of ulcer will be measured on days 0, 3, 5 and 7.
Other outcomes:
Locations:
city: Batman
country: Turkey
facility: Batman University
state: Centre/Batman
Study officials:
affiliation: Batman University
name: Rojdan F GÜNEŞ UYSAL, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Batman University
name: Giray G TEKİN, PhD
role: STUDY_DIRECTOR
References: