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

February 23, 2025 updated by: Rojdan Ferman GÜNEŞ UYSAL, Batman University

Comparative Evaluation of the Effect of Hypericum Perforatum on Pain Level in the Treatment of Recurrent Aphthous Stomatitis:A Randomized Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Centre/Batman
      • Batman, Centre/Batman, Turkey, 72100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Kenacort A Orabase® pomad , Bristol-Myers Squibb İlaçları Inc. İstanbul , Türkiye
Apply to the injured area 4 times a day
Other Names:
  • Kenacort A Orabase®
Active Comparator: 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.
Combination product: Hyaluronic acid, Aftamed ® Oral jel , AktiFarma . İstanbul, Türkiye
Apply to the injured area 4 times a day
Other Names:
  • Aftamed ®
Experimental: 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.
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
Other Names:
  • Zade Vital; Health&Fitness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level
Time Frame: Pain levels will be measured on days 0, 3, 5 and 7.
The pain level of the ulcer will be measured with a visual analogue scale (VAS) consisting of a 10- unıt horizontal line: "no pain (0)", "unbearable pain (10)"
Pain levels will be measured on days 0, 3, 5 and 7.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Size of ulcer
Time Frame: Size of ulcer will be measured on days 0, 3, 5 and 7.
The size of the ulcer will be measured with a vernier caliper
Size of ulcer will be measured on days 0, 3, 5 and 7.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Batman University

Investigators

  • Principal Investigator: Rojdan F GÜNEŞ UYSAL, PhD, Batman University
  • Study Director: Giray G TEKİN, PhD, Batman University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

April 15, 2025

Study Registration Dates

First Submitted

February 17, 2025

First Submitted That Met QC Criteria

February 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 23, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BatmanU-DF-RFGU-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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