ChiCTR-IPC-15007109已完成治疗新技术临床试验
電針灸聯合胃舒錠對比輪候電針灸聯合胃舒錠治療功能性消化不良：實況隨機對照試驗及經濟學評價
Health andMedical Research Fund1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 1990年1月1日最近更新:
试验速览
- 阶段
- 治疗新技术临床试验
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Binary assessment of adequate relief as primary endpoint
研究概览
简要总结
電針灸聯合胃舒錠與輪候電針灸聯合胃舒錠治療功能性消化不良患者的效果和成本效益比較
研究设计
- 研究类型
- 干预性研究
- 主要目的
- 随机平行对照
- 盲法
- None
入排标准
- 年龄范围
- 18 至 70（—）
- 性别
- All
入选标准
- •Patients who have completed oesophagogastroduodenoscopy (OGD) with H. pylori negative results, or patients who has tested positive for H. pylori but have completed medication course the for the eradication of H. pylori;
- •Patients with symptoms that fulfill the reference standard for Functional Dyspepsia Postprandial Distress Syndrome, including the presence of either or both of the following symptoms once per week in the past 1 month:postprandial fullness, early satiety. In accordance to the pragmatic approach of this trial, this reference standard is chosen as it reflects presentations of FD patients in real-world clinical settings, increasing the external validity of future results;
- •Voluntary discontinuation of any conventional pharmacological treatments for their functional dyspepsia 2 weeks prior to enrolment, due to perceived ineffectiveness;
- •Hong Kong permanent resident;
- •18 – 70 years of age.
排除标准
- •Patients who fulfill any of the following criteria would be excluded. Criteria will be assessed through patient history, medical record review, or physical examination.
- •Documented diagnosis of esophageal or gastric disease, including esophagitis, gastroesophageal reflux disease (GERD), peptic ulcer, predominant heartburn or acid regurgitation in the past 1 month;
- •Current regular user of non-steroidal anti-inflammatory drugs, anti-depressants or anxiolytic drugs, as defined as daily use in the past 2 months;
- •Patients who had received major abdominal surgery;
- •Patients who are pregnant;
- •Patients who are wearing cardiac pacemaker;
- •Patients who are having underlying major physical illness such as malignancy and infections;
- •Patients are using any dose of PPIs or prokinetics two weeks prior to enrollment;
- •For patients with coexisting IBS as diagnosed by the Manning criteria, exclusion is applied if a patient considers abdominal or bowel symptoms, instead of dyspepsia, as their major complaint. Manning criteria for Irritable Bowel Syndrome (IBS) is positive in this trial when ≥ 4 of the following symptoms are present in the past month: Visible abdominal distension, Pain relieved by a bowel action, More frequent stools with the onset of pain, Looser stools with the onset of pain, Rectal passage of mucus, A sensation of incomplete evacuation.
研究组 & 干预措施
Two groups
Electroacupuncture (EA) plus on-demand gastrocaine versus Waiting list to EA plus on-demand Gastrocaine
结局指标
主要结局
Binary assessment of adequate relief as primary endpoint
时间窗: Measure time point of outcome：Data on the primary outcome of adequate relief will be assessed via a weekly standardized phone interview by blinded assessors at baseline and over the entire trial period.
次要结局
- Nepean Dyspepsia Index (NDI)(Assessment of the outcome will be performed at baseline and 12th week.)
- Patient Health Questionnaire 9 (PHQ9)(Assessment of the outcome will be performed at baseline and 12th week via face to face interview and at bi-weekly interval over 12 weeks via phone interview.)
- Patient Health Questionnaire section for Anxiety (GAD7)(Assessment of the outcome will be performed at baseline and 12th week via face to face interview and at bi-weekly interval over 12 weeks via phone interview.)
- Nutrient Drink Test (NDT)(Assessment of the outcome will be performed at baseline and 12th week.)
- Adverse Events Questionnaire(Adverse events (AE) will be monitored at weekly interval over 12 weeks via phone interview.)
- EuroQol (EQ-5D) questionnaire to estimate Quality-adjusted life-years (QALYs) gained(Assessment of the outcome will be performed at baseline and 12th week via face to face interview and at weekly interval over 12 weeks via phone interview.)
- Patient reported change in individual symptoms(Assessment of the outcome will be performed at baseline and 12th week via face to face interview and at weekly interval over 12 weeks via phone interview.)
- Patient reported change in global symptoms(Assessment of the outcome will be performed at baseline and 12th week via face to face interview and at weekly interval over 12 weeks via phone interview.)
- Direct medical cost associated with the management of FD(Assessment of the outcome will be performed at baseline and 12th week via face to face interview and at weekly interval over 12 weeks via phone interview.)
研究者
研究点 (1)
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