NCT06839313

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

February 17, 2025

Last Update Submit

February 23, 2025

Conditions

Stomatitis, Aphthous

Keywords

RehabilitationHypericum perforatumPainHyaluronic AcidCorticosteroid

Outcome Measures

Primary Outcomes (1)

  • Pain level

    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 Outcomes (1)

  • Size of ulcer

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

Study Arms (3)

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.

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.

Combination Product: Hyaluronic acid, Aftamed ® Oral jel , AktiFarma . İstanbul, Türkiye

grup 3 St. John's wort oil

EXPERIMENTAL

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

Interventions

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

Apply to the injured area 4 times a day

Also known as: Kenacort A Orabase®
group 1 Triamsinolon asetonid
Hyaluronic acid, Aftamed ® Oral jel , AktiFarma . İstanbul, TürkiyeCOMBINATION_PRODUCT

Apply to the injured area 4 times a day

Also known as: Aftamed ®
grup 2 Hyaluronic acid
St. John's wort oil, Zade Vital; Health&Fitness, Developed With Ege Üniversiesi ArgefarCOMBINATION_PRODUCT

Apply to the injured area 4 times a day

Also known as: Zade Vital; Health&Fitness
grup 3 St. John's wort oil

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Batman University

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

RECRUITING

MeSH Terms

Conditions

Stomatitis, AphthousPain

Interventions

Hyaluronic AcidHypericum extract LI 160

Condition Hierarchy (Ancestors)

StomatitisMouth DiseasesStomatognathic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Rojdan F GÜNEŞ UYSAL, PhD

    Batman University

    PRINCIPAL INVESTIGATOR

  • Giray G TEKİN, PhD

    Batman University

    STUDY DIRECTOR

Central Study Contacts

Rojdan F GÜNEŞ UYSAL, PhD

CONTACT

05433796751rojdangunes@hotmail.com

Giray G TEKİN, PhD

CONTACT

05052601118dt.giray@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The patients and the second researcher who recorded the patients' symptoms were kept unaware of the treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: patients were divided into three groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 17, 2025

First Posted

February 21, 2025

Study Start

February 1, 2025

Primary Completion

March 31, 2025

Study Completion

April 15, 2025

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)