Comparative Evaluation of Hypericum Perforatum, Topical Corticosteroids, and Hyaluronic Acid in the Treatment of Recurrent Aphthous Stomatitis: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Pain level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The investigator responsible for outcome assessment was blinded to treatment allocation. Due to the nature of the interventions, neither the participants nor the investigator administering the treatments could be blinded.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Kenacort A Orabase® pomad , Bristol-Myers Squibb İlaçları Inc. İstanbul , Türkiye (Drug)
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.
干预措施: Hyaluronic acid, Aftamed ® Oral jel , AktiFarma . İstanbul, Türkiye (Combination Product)
结局指标
主要结局
Pain level
时间窗: 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.
次要结局
- Size of ulcer(Size of ulcer will be measured on days 0, 3, 5 and 7.)
- Ulcer healing duration(Up to 7 days)
研究者
Rojdan Ferman GÜNEŞ UYSAL
Assistant professor
Batman University