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Comparison of HATAKABB Anti-Cough Mouth Spray and 0.1% Triamcinolone Acetonide Mouth Spray in Treatment of Recurrent Aphthous Stomatitis

Comparison of HATAKABB Anti-Cough Mouth Spray and 0.1% Triamcinolone Acetonide Mouth Spray in Treatment of Recurrent Aphthous Stomatitis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251229020
Enrollment
72
Registered
2025-12-29
Start date
2025-12-26
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy human volunteers with recurrent aphthous stomatitis attending the Oral Medicine Clinic, Faculty of Dentistry, Chiang Mai University, Thailand Recurrent Aphthous Stomatitis, Triamcinolone Acetonide, HATAKABB

Interventions

Apply topically 3 times daily for 7 days,Apply topically 3 times daily for 7 days
Experimental Drug,Active Comparator Drug
HATAKABB ,Triamcinolone Acetonide

Sponsors

Faculty of Dentistry, Chiang Mai University
Lead Sponsor
HATAKABB (Sim Tien Hor) Co., Ltd.
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age over 18 years 2. Clinically diagnosed with RAS, with an ulcer diameter less than 10 mm 3. Willingness to participate and provide informed consent

Exclusion criteria

Exclusion criteria: 1. Known allergy to HATAKABB Anti-cough Mouth Spray 2. Pregnancy or breastfeeding 3. Presence of RAS secondary to systemic diseases associated with oral ulceration (e.g., Behcet disease, Reiter syndrome, inflammatory bowel disease, cyclic neutropenia of unknown etiology, AIDS, pernicious anemia, nutritional deficiencies) 4. Ulcers caused by bacterial, fungal, or viral infections 5. Use of corticosteroids within the past week 6. Use of analgesics or nonsteroidal anti-inflammatory drugs within the past 48 hours

Design outcomes

Primary

MeasureTime frame
Ulcer size Baseline and Day 7 Calibrated periodontal probe

Secondary

MeasureTime frame
Healing time Complete ulcer resolution Self-reported by participants,Pain intensity Baseline and Day 7 VAS,Salivary TNF-alpha levels Baseline and Day 7 Commercial enzyme-linked immunosorbent assay

Countries

Thailand

Contacts

Public ContactJitjiroj Ittichaicharoen

Faculty of Dentistry, Chiang Mai University

jitjiroj.itti@cmu.ac.th053944495

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026