Stomatitis, AphthousNCT06839313
Comparison of Hypericum Perforatum, Topical Corticosteroids, and Hyaluronic Acid for Recurrent Aphthous Stomatitis
A study testing Kenacort A Orabase® pomad , Bristol-Myers Squibb İlaçları Inc. İstanbul , Türkiye, Hyaluronic acid, Aftamed ® Oral jel , AktiFarma . İstanbul, Türkiye and Hypericum perforatum (St. John's wort oil, Zade Vital; Health&Fitness, Developed With Ege Üniversiesi Argefar) in people with Stomatitis, Aphthous, run by Batman University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Stomatitis, Aphthous
- What is being tested?
- Kenacort A Orabase® pomad , Bristol-Myers Squibb İlaçları Inc. İstanbul , Türkiye, Hyaluronic acid, Aftamed ® Oral jel , AktiFarma . İstanbul, Türkiye and Hypericum perforatum (St. John's wort oil, Zade Vital; Health&Fitness, Developed With Ege Üniversiesi Argefar)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 years and over
- Having a history of RAS for at least 2 years
- Having one in an easily accessible area in the mouth
- RAS has not exceeded a period of 48 hours
Who cannot join
- Having any allergic history to these substances to be applied
- During pregnancy and lactation
- Use of steroids, vitamins, antibiotics, antihistamines, oral retinoids or immune system regulating agents for ulcer treatment within 3 months
- The patient has a history of systemic disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Batman University
Batman, Centre/Batman, 72100
About this study
Official title: 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.
Read the 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.
- Conditions
- Stomatitis, Aphthous
- Being tested
- Kenacort A Orabase® pomad , Bristol-Myers Squibb İlaçları Inc. İstanbul , Türkiye, Hyaluronic acid, Aftamed ® Oral jel , AktiFarma . İstanbul, Türkiye, Hypericum perforatum (St. John's wort oil, Zade Vital; Health&Fitness, Developed With Ege Üniversiesi Argefar)
- Keywords
- Rehabilitation, Hypericum perforatum, Pain, Hyaluronic Acid, Corticosteroid
- Medical subject headings
- Stomatitis, Aphthous, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kenacort A Orabase® pomad , Bristol-Myers Squibb İlaçları Inc. İstanbul , TürkiyeDrug
Also called Kenacort A Orabase®
Apply to the injured area 4 times a day
Hyaluronic acid, Aftamed ® Oral jel , AktiFarma . İstanbul, TürkiyeCombination product
Also called Aftamed ®
Apply to the injured area 4 times a day
Hypericum perforatum (St. John's wort oil, Zade Vital; Health&Fitness, Developed With Ege Üniversiesi Argefar)Combination product
Also called Zade Vital; Health&Fitness
Apply to the injured area 4 times a day
| Study group | Role | What they receive |
|---|---|---|
| group 1 Triamsinolon asetonid | Active comparator | % 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. Receives: Drug: Kenacort A Orabase® pomad , Bristol-Myers Squibb İlaçları Inc. İstanbul , Türkiye |
| grup 2 Hyaluronic acid | Active comparator | 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. Receives: Combination Product: Hyaluronic acid, Aftamed ® Oral jel , AktiFarma . İstanbul, Türkiye |
| grup 3 St. John's wort oil | Experimental | 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. Receives: Combination Product: Hypericum perforatum (St. John's wort oil, Zade Vital; Health&Fitness, Developed With Ege Üniversiesi Argefar) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
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.
Measured: Pain levels will be measured on days 0, 3, 5 and 7.
Secondary outcomes (2)
Size of ulcer
The size of the ulcer will be measured with a vernier caliper(mm)
Measured: Size of ulcer will be measured on days 0, 3, 5 and 7.
Ulcer healing duration
Time required for complete ulcer healing, defined as complete epithelialization without visible ulceration.
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Feb 2025
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomatitis, AphthousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients were divided into three groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rojdan Ferman GÜNEŞ UYSAL, Batman University
- Investigators
- Rojdan F GÜNEŞ UYSAL, PhD, Principal investigator, Batman UniversityGiray G TEKİN, PhD, Study director, Batman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839313
- Sponsor's protocol ID
- BatmanU-DF-RFGU-01
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Hypericum Perforatum, Topical Corticosteroids, and Hyaluronic Acid in the Treatment of Recurrent Aphthous Stomatitis: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06839313
- Acronym / sponsor ID
- BatmanU-DF-RFGU-01
- Conditions
- Stomatitis, Aphthous
- Keywords
- Rehabilitation, Hypericum perforatum, Pain, Hyaluronic Acid, Corticosteroid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Batman UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- patients were divided into three groups
| Arm | Type | Receives |
|---|---|---|
| group 1 Triamsinolon asetonid | Active comparator | Drug: Kenacort A Orabase® pomad , Bristol-Myers Squibb İlaçları Inc. İstanbul , Türkiye% 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. |
| grup 2 Hyaluronic acid | Active comparator | Combination Product: Hyaluronic acid, Aftamed ® Oral jel , AktiFarma . İstanbul, TürkiyeHyaluronic 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. |
| grup 3 St. John's wort oil | Experimental | Combination Product: Hypericum perforatum (St. John's wort oil, Zade Vital; Health&Fitness, Developed With Ege Üniversiesi Argefar)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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 years and over
- Having a history of RAS for at least 2 years
- Having one in an easily accessible area in the mouth
- RAS has not exceeded a period of 48 hours
Key exclusion criteria (4 listed)
- Having any allergic history to these substances to be applied
- During pregnancy and lactation
- Use of steroids, vitamins, antibiotics, antihistamines, oral retinoids or immune system regulating agents for ulcer treatment within 3 months
- The patient has a history of systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kenacort A Orabase® pomad , Bristol-Myers Squibb İlaçları Inc. İstanbul , TürkiyeAlso: Kenacort A Orabase®Apply to the injured area 4 times a day | Drug | group 1 Triamsinolon asetonid |
| Hyaluronic acid, Aftamed ® Oral jel , AktiFarma . İstanbul, TürkiyeAlso: Aftamed ®Apply to the injured area 4 times a day | Combination product | grup 2 Hyaluronic acid |
| Hypericum perforatum (St. John's wort oil, Zade Vital; Health&Fitness, Developed With Ege Üniversiesi Argefar)Also: Zade Vital; Health&FitnessApply to the injured area 4 times a day | Combination product | grup 3 St. John's wort oil |
Primary outcome
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.
2 secondary outcomes
Size of ulcer
Time frame: Size of ulcer will be measured on days 0, 3, 5 and 7.
Ulcer healing duration
Time frame: Up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rojdan F GÜNEŞ UYSAL, PhD principal investigator
Batman University
Giray G TEKİN, PhD study director
Batman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kenacort A Orabase® pomad , Bristol-Myers Squibb İlaçları Inc. İstanbul , Türkiye, Hyaluronic acid, Aftamed ® Oral jel , AktiFarma . İstanbul, Türkiye and Hypericum perforatum (St. John's wort oil, Zade Vital; Health&Fitness, Developed With Ege Üniversiesi Argefar) in people with Stomatitis, Aphthous, run by Batman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: Pain levels will be measured on days 0, 3, 5 and 7.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.