Effect of St. John's Wort in the Treatment of Recurrent Aphthous Stomatitis

Batman University

Status: Enrolling

Conditions: Stomatitis, Aphthous

Treatments: Combination Product: Hyaluronic acid, Aftamed ® Oral jel , AktiFarma . İstanbul, Türkiye; Combination Product: St. John's wort oil, Zade Vital; Health&Fitness, Developed With Ege Üniversiesi Argefar; Drug: Kenacort A Orabase® pomad , Bristol-Myers Squibb İlaçları Inc. İstanbul , Türkiye

Study type: Interventional

Funder types: Other

Identifiers

NCT06839313

BatmanU-DF-RFGU-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups

group 1 Triamsinolon asetonid

Active Comparator group

Description:

% 0,1 Triamsinolon asetonid (Kenacort- A orabase pomad) will be used on ulcer areas 4 times a day (after meals and before going to bed) for 7 days.

Treatment:

Drug: Kenacort A Orabase® pomad , Bristol-Myers Squibb İlaçları Inc. İstanbul , Türkiye

grup 2 Hyaluronic acid

Active Comparator group

Description:

Hyaluronic acid gel (Aftamed ® Oral gel, AktiFarma, Istanbul, Turkey) will be used on ulcer areas 4 times a day (after meals and before bedtime) for 7 days.

Treatment:

Combination Product: Hyaluronic acid, Aftamed ® Oral jel , AktiFarma . İstanbul, Türkiye

grup 3 St. John's wort oil

Experimental group

Description:

St. John's wort oil (Zade Vital; Health\&Fitness, Developed With Ege University Argefar) will be used on ulcer areas 4 times a day (after meals and before going to bed) for 7 days.

Treatment:

Combination Product: St. John's wort oil, Zade Vital; Health&Fitness, Developed With Ege Üniversiesi Argefar