ClinicalTrials.gg
CompletedNCT06839313Updated Jul 8, 2026

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

An interventional study of Kenacort A Orabase® pomad , Bristol-Myers Squibb İlaçları Inc. İstanbul , Türkiye and Hyaluronic acid, Aftamed ® Oral jel , AktiFarma . İstanbul, Türkiye in Stomatitis, Aphthous, sponsored by Batman University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by Batman University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Stomatitis, Aphthous

Keywords

  • Rehabilitation
  • Hypericum perforatum
  • Pain
  • Hyaluronic Acid
  • Corticosteroid
03

In context

Stomatitis, Aphthous

63 studies on the registry are indexed under Stomatitis, Aphthous; 17 are open to participants now.

This study's enrollment of 75 is above the median of 41 across 54 interventional studies indexed under Stomatitis, Aphthous.

Browse Stomatitis, Aphthous studies →

Lead sponsor

Batman University is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Having any allergic history to these substances to be applied
  2. During pregnancy and lactation
  3. Use of , 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
75 participants (actual)

Study arms

  • 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

  • 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

  • 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)

Interventions

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

    Apply to the injured area 4 times a day

    Also known as: Kenacort A Orabase®

  • Combination productHyaluronic acid, Aftamed ® Oral jel , AktiFarma . İstanbul, Türkiye

    Apply to the injured area 4 times a day

    Also known as: Aftamed ®

  • Combination productHypericum perforatum (St. John's wort oil, Zade Vital; Health&Fitness, Developed With Ege Üniversiesi Argefar)

    Drug page: Hypericum perforatum

    Apply to the injured area 4 times a day

    Also known as: Zade Vital; Health&Fitness

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Pain levels will be measured on days 0, 3, 5 and 7.

Secondary outcomes

  1. Size of ulcer

    The size of the ulcer will be measured with a vernier caliper(mm)

    Time frame: Size of ulcer will be measured on days 0, 3, 5 and 7.

  2. Ulcer healing duration

    Time required for complete ulcer healing, defined as complete epithelialization without visible ulceration.

    Time frame: Up to 7 days

07

Study locations

1 site
  • Batman University
    Batman, Centre/Batman 72100, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06839313
Lead sponsor
Batman University
Responsible party
Rojdan Ferman GÜNEŞ UYSAL (Assistant professor, Batman University) — Principal investigator
First posted
Feb 21, 2025
Start date
Feb 1, 2025
Primary completion
Aug 15, 2025
Completion
Aug 15, 2025
Last update
Jul 8, 2026

Study contacts

Rojdan F GÜNEŞ UYSAL, PhD
principal investigator · Batman University
Giray G TEKİN, PhD
study director · Batman University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Hypericum perforatum

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