NCT04398888已完成不适用
Efficacy of a Modified Banxia Xiexin Decoction (BXD) for the "Wei-Pi" Syndrome (Postprandial Distress Syndrome): a Randomized, Waitlist Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Change of the Quality of Life Questionnaire for Functional Digestive Disorders
研究概览
简要总结
The study aims to evaluate the efficacy of a modified Banxia Xiexin Decoction (BXD) for Wei-Pi through a randomized, waitlist controlled trial.
详细描述
After being informed about the study plan, potential risk and benefits, all subjects will give written informed consent prior to participation and undergo eligibility screening. Eligible participants will be randomized, in a 1:1 ratio, into BXD group and waitlist group.
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
- None
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
- •Permanent resident of Hong Kong with age from 18 to 60
- •Have a diagnosis of Wei-Pi (postprandial distress syndrome, ie. at least one of bothersome postprandial fullness (ie, severe enough to impact on usual activities) and bothersome early satiation (ie, severe enough to prevent finishing a regular-size meal) at least three days per week for the last three months, with symptom onset at least six months before diagnosis
排除标准
- •Pregnancy or pregnancy planners
- •Abnormal liver function (up to twofold the upper normal reference level of ALT)[14] or kidney function (estimated creatinine clearance < 80 mL/min)[15]
- •History of diagnosed gastric structural abnormalities through endoscopy /History of gastric removal surgery
- •Have G6PD deficiency
- •Alcohol or drug abuser
- •Taking Chinese medicine within one month
- •Unable to read/understand and sign the informed consent document
结局指标
主要结局
Change of the Quality of Life Questionnaire for Functional Digestive Disorders
时间窗: Change from baseline score at 3 weeks.
Quality of Life Questionnaire for Functional Digestive Disorders (FDDQL)
次要结局
- The Hospital Anxiety and Depression Scale(Weeks 0, 3, and 7)
- Kidney function test(Weeks 0 and 3.)
- Liver function test(Weeks 0 and 3.)
- Quality of Life Questionnaire for Functional Digestive Disorders(Weeks 0, 3, and 7)
- EQ-5D-5L(Weeks 0, 1, 2, 3, 4, and 7)
研究者
研究点 (1)
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