Effect of Jaeumgeonbi-Tang on Chronic Subjective Dizziness: A Randomized, Double-Blind, Parallel-group, Placebo-Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Dizziness handicap Inventory
研究概览
简要总结
The goal of this study is to assess the safety and efficacy of JGT (Jaeumgeonbi-Tang). A randomized, double-blind, parallel-group, placebo-controlled clinical trial was conducted and changes in symptoms and quality of life of the patients were evaluated.
详细描述
This study's protocol was designed to assess the efficacy of JGT (Jaeumgeonbi-Tang) for chronic subjective dizziness.
- This design of the study is a randomized, double-blind, parallel-group, placebo-controlled design.
- Symptoms and quality of life of chronic subjective dizziness patients will be evaluated.
- Dizziness severity and quality of life of the patients will be evaluated using DHI (Dizziness Handicap Inventory) (1) before treatment (baseline), (2) after 2 weeks, and (3) after 4 weeks of JGT treatment.
- Blood samples of the patients will be gathered before and after JGT treatment for pathophysiological analysis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
JGT group
Treatment group: JGT (Jaeumgeonbi-Tang) tablet. 8 g t.i.d. for 28 days
干预措施: JGT (Jaeumgeonbi-Tang) tablet (Drug)
Placebo group
Placebo group: Corn starch tablet, 8 g t.i.d. for 28 days
干预措施: Placebo tablet (Drug)
结局指标
主要结局
Dizziness handicap Inventory
时间窗: Change from Baseline DHI score at 4 weeks
The DHI (Dizziness Handicap Inventory) is a 25-item self-report questionnaire that quantifies the effect of dizziness on daily life by measuring the self-perceived handicap of the patients.
次要结局
未报告次要终点
研究者
HoRyong Yoo
Associate Professor, Daejeon University
Korea Health Industry Development Institute