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

NCT ID: NCT06839313

Last Updated: 2025-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-04-15

Brief Summary

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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

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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.

Conditions

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Stomatitis, Aphthous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

patients were divided into three groups
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The patients and the second researcher who recorded the patients' symptoms were kept unaware of the treatment.

Study Groups

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group 1 Triamsinolon asetonid

% 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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Apply to the injured area 4 times a day

grup 2 Hyaluronic acid

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.

Group Type ACTIVE_COMPARATOR

Hyaluronic acid, Aftamed ® Oral jel , AktiFarma . İstanbul, Türkiye

Intervention Type COMBINATION_PRODUCT

Apply to the injured area 4 times a day

grup 3 St. John's wort oil

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.

Group Type EXPERIMENTAL

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

Intervention Type COMBINATION_PRODUCT

Apply to the injured area 4 times a day

Interventions

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

Apply to the injured area 4 times a day

Intervention Type DRUG

Hyaluronic acid, Aftamed ® Oral jel , AktiFarma . İstanbul, Türkiye

Apply to the injured area 4 times a day

Intervention Type COMBINATION_PRODUCT

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

Apply to the injured area 4 times a day

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Kenacort A Orabase® Aftamed ® Zade Vital; Health&Fitness

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Batman University

OTHER

Sponsor Role lead

Responsible Party

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Rojdan Ferman GÜNEŞ UYSAL

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rojdan F GÜNEŞ UYSAL, PhD

Role: PRINCIPAL_INVESTIGATOR

Batman University

Giray G TEKİN, PhD

Role: STUDY_DIRECTOR

Batman University

Locations

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Batman University

Batman, Centre/Batman, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Rojdan F GÜNEŞ UYSAL, PhD

Role: CONTACT

05433796751

Giray G TEKİN, PhD

Role: CONTACT

05052601118

Facility Contacts

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Veysel ERATİLLA, PhD

Role: primary

05053525740

Other Identifiers

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BatmanU-DF-RFGU-01

Identifier Type: -

Identifier Source: org_study_id

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