Acupuncture of Different Treatment Frequency on Improving Quality of Life in Patients With Functional Dyspepsia: a Three-armed Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- The score change in Nepean Dyspepsia Life Quality Index compared with baseline at week 4
研究概览
简要总结
The objective of this trial is to assess acupuncture of different treatment frequency on improving quality of life in patients with functional dyspepsia.
详细描述
The effect of treatment frequency of acupuncture on the functional dyspepsia is unclear. In this study, 60 participants with FD will be recruited and randomly allocated (using a 1:1:1 allocation ratio) into three times a week group, once a week group and waiting for treatment group. Participants will receive acupuncture treatment at bilateral Zhongwan（CV12）, Tianshu（ST25）, Neiguan（PC6）, Liangqiu（ST34）, Yanglinquan（GB34）, Zusanli（ST36）and Taichong（LR3) of different treatment frequency for 4 weeks. This trial is designed to analyze the acupuncture of different treatment frequency on improving quality of life in patients with FD and to provide evidence for the establishment of acupuncture treatment quantization standard of FD.
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 (Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Diagnosis of FD as defined by the Roman IV Functional Dyspepsia Diagnostic criteria
- •One or more of the following:
- •Bothersome postprandial fullness
- •Bothersome early satiation
- •Bothersome epigastric pain
- •Bothersome epigastric burning AND No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms Epigastric Pain Syndrome (EPS) criteria: fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.
- •Postprandial Distress Syndrome Diagnostic (PDS) criteria: must include one or both of the following at least 3 days per week:
- •Age 18-75 years.
- •Signed informed consent and volunteered to participate in the trial.
排除标准
- •Candidate participants with any of the following items will be excluded from this trial.
- •Gastrointestinal motility drugs taken within the past 15 days; Acupuncture treatments within the past 30 days; participating in other ongoing clinical trials
- •Severe heart, lung, liver, brain or kidney damage.
- •Would-be mothers, pregnant or lactation;
- •Progressive malignant tumor or other severe consumptive diseases, easy to be complicated with bleeding and infection;
- •Cognitive impairment such as unable to express subjective symptoms of discomfort or give informed consent.
结局指标
主要结局
The score change in Nepean Dyspepsia Life Quality Index compared with baseline at week 4
时间窗: week 4
The primary outcome is the score change in Nepean Dyspepsia Life Quality Index （NDLQI）compared with baseline at week 4. The NDLQI is a scale of 25 items about the quality of the patients' life with a ranging score of 1-4 of each item. The higher scores indicates a worse outcome.
次要结局
- 6. The standard score change in Self-Rating Depression Scale （SDS）(week 4, week 8 and week 12)
- The total score change in Symptom Index of Dyspepsia （SID）(week 4, week 8 and week 12)
- The score change in NDLQI compared with baseline(week 2, week 8 and week 12)
- The score of each dimension change in NDLQI compared with baseline(week 4, week 8 and week 12)
- The standard score change in Self-Rating Anxiety Scale（SAS）(week 4, week 8 and week 12)
研究者
Biyun Sun
Department of Acupuncture doctor in Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Guang'anmen Hospital of China Academy of Chinese Medical Sciences