Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome Using a Topical Gel
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evolution of burning mouth
研究概览
简要总结
A double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of alpha lipoic acid (ALA) and determine the statistical significance of the outcome variables. Burning mouth syndrome (BMS) is defined as an oral burning sensation in the absence of clinical signs which could justify the syndrome.
Recent studies suggest the existence of neurological factors as a possible cause of the disease.
详细描述
A double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of alpha lipoic acid (ALA) and determine the statistical significance of the outcome variables.
60 patients with BMS, in two groups: case group with 600 mg/day and placebo as control group; with a follow-up of 2 months.
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)
盲法说明
Sealed envelopes
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •clinically diagnosed with BMS who reported a history of continuous oral burning pain for more than 4 months with no clinical signs that could justify the syndrome
排除标准
- •clinically diagnosed with BMS who reported a history of continuous oral burning pain for more than 4 months with no clinical signs that could justify the syndrome
研究组 & 干预措施
Lipoic acid gel
Patients were treated with a topic gel of lipoic acid
干预措施: Lipoid acid gel (Other)
Placebo
Patients treated with a placebo gel control
干预措施: Placebo (Drug)
结局指标
主要结局
Evolution of burning mouth
时间窗: 6 months
Evolution of burning mouth symptoms change through a questionnaire
次要结局
未报告次要终点
研究者
Gaetano Isola
Researcher
University of Catania