Efficacy of a Modified Banxia Xiexin Decoction (BXD) for the "Wei-Pi" Syndrome (Postprandial Distress Syndrome): a Randomized, Waitlist Controlled Trial
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
研究组 & 干预措施
BXD treatment
Participants will be diagnosed and treated by Chinese medicine practitioners (CMPs) with at least 5 years of clinical experience. CMPs will differentiate syndrome and prescript herbs in a semi-standardized protocol, which consists of a base Chinese medicine decoction, Banxia Xiexin Decoction (BXD), and the additional syndrome-specific herbs.
The modified decoction will be prepared in a conventional decocting method at the Chinese medicine pharmacy in the clinic (HKBA-HKU CMCTR) and will be packaged into bags by the auto-decocting machines. Participants will take the decoction twice per day, 5 days per week, for 3 weeks.
干预措施: Banxie Xiexin Decoction (BXD) (Other)
Waitlist
Participants in the waiting list control group will be observed for a three-week waiting period. Rescue medication is not restricted.
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)