Comparison of Hypericum Perforatum, Topical Corticosteroids, and Hyaluronic Acid for Recurrent Aphthous Stomatitis

July 5, 2026 updated by: Rojdan Ferman GÜNEŞ UYSAL, Batman University

Comparative Evaluation of Hypericum Perforatum, Topical Corticosteroids, and Hyaluronic Acid in the Treatment of Recurrent Aphthous Stomatitis: A Randomized Controlled Study

Recurrent aphthous stomatitis (RAS) is one of the most common ulcerative diseases of the oral mucosa and is characterized by recurrent painful ulcers that adversely affect eating, speaking, and overall quality of life. Although several topical agents are available to relieve symptoms and promote healing, no definitive treatment has yet been established.

This randomized prospective study was designed to compare the clinical effectiveness of Hypericum perforatum, topical corticosteroids, and hyaluronic acid in patients with recurrent aphthous stomatitis. The primary outcome was pain reduction, while secondary outcomes included ulcer size reduction and healing duration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The etiology of recurrent aphthous stomatitis (RAS) remains incompletely understood. Various topical and systemic therapeutic approaches have been proposed to reduce pain, accelerate ulcer healing, and improve patients' quality of life. Topical agents remain the first-line treatment for symptomatic management of RAS.

Triamcinolone acetonide (TA), a topical corticosteroid with potent anti-inflammatory properties, is widely used in the treatment of RAS. Hyaluronic acid (HA) gel has also demonstrated favorable clinical outcomes by reducing pain and promoting ulcer healing without significant adverse effects. In addition, Hypericum perforatum (St. John's wort) possesses anti-inflammatory, antimicrobial, antioxidant, and wound-healing properties, suggesting its potential as an alternative topical treatment for RAS.

This randomized prospective study was designed to compare the clinical effectiveness of topical Hypericum perforatum, topical triamcinolone acetonide, and hyaluronic acid gel in patients with recurrent aphthous stomatitis. The primary outcome was pain reduction, whereas secondary outcomes included ulcer size reduction and healing duration.

Study Type

Interventional

Enrollment (Actual)

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 Locations

  • Turkey (Türkiye)
    • Centre/Batman
      • Batman, Centre/Batman, Turkey (Türkiye), 72100
        • Batman University

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: Single

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
Hypericum perforatum (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: Hypericum perforatum (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.
Pain intensity will be assessed using a 10-cm visual analogue scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
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(mm)
Size of ulcer will be measured on days 0, 3, 5 and 7.
Ulcer healing duration
Time Frame: Up to 7 days
Time required for complete ulcer healing, defined as complete epithelialization without visible ulceration.
Up to 7 days

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 (Actual)

August 15, 2025

Study Completion (Actual)

August 15, 2025

Study Registration Dates

First Submitted

February 17, 2025

First Submitted That Met QC Criteria

February 17, 2025

First Posted (Actual)

February 21, 2025

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

July 5, 2026

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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