Efficacy and Safety Study of Yunnan Baiyao on Minor Recurrent Aphthous Stomatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 227
- 主要终点
- Ulcer size
研究概览
简要总结
Recurrent aphthous stomatitis (RAS) is a common recurrent oral disorder with no curative treatment available to date. The challenge remains in patients that do develop drug resistance and/or secondary infection, although topical corticosteroids and antimicrobials are the first therapeutic choice. The aim of the study was to evaluate the efficacy and safety of an herbal extract of Yunnan Baiyao formulated in toothpaste as an alternative therapy for minor RAS.
Yunnan Baiyao is a well-known traditional Chinese medicine, formulated in a powder or capsule form. It was initially and widely used in wounds for its anti-hemorrhagic hemostatic function, and further in gastrointestinal bleeding. Yunnan Baiyao powder has been generally applied on RAS among Chinese population.
In this study, a randomized, double-blind, placebo-controlled clinical trial (from March 2010 to March 2011) was conducted on a cohort of 227 minor RAS patients. The toothpaste containing Yunnan Baiyao was used twice daily as part of the patient's routine oral hygiene for 5 days. An assessment of ulcerative size and pain was recorded on Day 0 (baseline), Day 3 and Day 5. Any noted adverse reactions were recorded.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both male and female aged 18 to 65 years old;
- •Patients diagnosed as minor recurrent aphthous stomatitis with the duration of each ulcer in excess of 5 days;
- •Fresh ulcers available with less than 72 hours eruption.
排除标准
- •Hypersensitive to various medical agents;
- •Concurrent acute infectious disease;
- •Pregnancy or lactation;
- •Concurrent other immunology disorders;
- •Accepting systemic administration of corticosteroids or immunosuppressive agents within 3 months;
- •Aphthous-like ulcers related to certain systemic disorders such as ulcerative colitis, Crohn's disease, Behcet's syndrome, serious anemia;
- •Aphthous-like ulcers related to drug such as non-steroidal anti-inflammatory drugs (NSAIDs) and anti-histamines;
- •Accepting anaesthetic therapy within 24 hours, or systemic antibiotics within 2 weeks, or other management for oral ulcers within 72 hours prior to the study;
- •Neoplasm patients;
- •Volunteers of other clinical trials on medical agents or toothpaste within one month.
研究组 & 干预措施
Yunnan Baiyao toothpaste
The toothpaste containing 6.5 milligrams of Yunnan Baiyao was used twice daily as part of the patient's routine oral hygiene for 5 days.
干预措施: Yunnan Baiyao toothpaste (Drug)
placebo toothpaste
One gram of placebo toothpaste was used twice daily by the control group patients. Except for the active Yunnan Baiyao extract, all ingredients contained in the placebo-toothpaste were the same as that in the experimental toothpaste.
干预措施: Placebo toothpaste (Drug)
结局指标
主要结局
Ulcer size
时间窗: one year
The assessment of the surface area of the ulcer was measured in millimeters by a dental probe. Ulcer size was assessed as the product of maximum diameter and its vertical diameter.
次要结局
- Number of the participants with adverse events(one year)
- Pain Scores with Visual Analog Scale(one year)
研究者
Xiaosong Liu
associate professor
Peking University