Comparative Evaluation of Aged Garlic extract and Triamcinolone Acetonide in minor Recurrent Aphthous Stomatitis. A randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- USS ulcerative severity score, (OHIS) Oral
研究概览
简要总结
This study is randomized, parallel arm, open label clinical trial study considering the benefits of anti-inflammatory, anti-bacterial and immune modulatory properties of aged garlic extract, Aged garlic extract (AGE) capsules could be tried to evaluate its effect in Recurrent Aphthous Stomatitis(RAS). Also comparing it with first line therapy that is topical steroid would further help in exploring its effectiveness. Therefore this study is planned to evaluate the effectiveness of Aged garlic extract capsules in Recurrent Apthous stoamtatitis as compared to topical triamcenolone acetonide buccal paste (considered as the first line therapy in RAS) alone and dual therapy of AGE capsules and triamcenolone acetonide buccal paste.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with minor recurrent aphthous stomatitis, Presenting with single or multiple minor aphthous ulcers of more than 48 hours duration, Ulcers must be in locations easily accessible for evaluation and treatment, such as the buccal mucosa, labial mucosa, floor of the mouth, or tongue.
- •Diagnosed with RAS according to the original criteria of Lehner (1968).
排除标准
- •History of allergies to garlic and triamcinolone acetonide, Patients with recurrent aphthous ulcer major and recurrent herpetiform ulcer, Patient already undergoing treatment for recurrent aphthous Stomatitis, Pregnant and lactating females, Patients on medication for any reason (oral problems, systemic Problems), Patients with any systemic problem or syndrome, Ulcers as a manifestation of systemic diseases.
结局指标
主要结局
USS ulcerative severity score, (OHIS) Oral
时间窗: Patient will be recalled at the end of 4 th day, 7 th day,14 th day | • Post treatment follow up will be done on | monthly basis for three months (30 th day, 60 th day, 90 th day) | • Evaluation of the following parameters | will be done on each visit | 1.Ulcer Severity Score(USS) | 2.Oral health impact score(OHIS) | 3.Adverse effects if any | - If Recurrence occurs, standard treatment (Triamcinolone Acetonide | 0.1% buccal paste) will be provided.
health impact score
时间窗: Patient will be recalled at the end of 4 th day, 7 th day,14 th day | • Post treatment follow up will be done on | monthly basis for three months (30 th day, 60 th day, 90 th day) | • Evaluation of the following parameters | will be done on each visit | 1.Ulcer Severity Score(USS) | 2.Oral health impact score(OHIS) | 3.Adverse effects if any | - If Recurrence occurs, standard treatment (Triamcinolone Acetonide | 0.1% buccal paste) will be provided.
次要结局
- Side effects of intervention, if any(Patient will be recalled at the end of 4th day, 7th)
研究者
Rutuja Kadam
Government Dental College And Hospital Nagpur