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【ChiCTR-IPC-15007109】電針灸聯合標準療法治療難治性功能性消化不良：實況隨機對照試驗及經濟學評價

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基本信息

登记号

ChiCTR-IPC-15007109

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2015-09-18

临床申请受理号

靶点

适应症

功能性消化不良

试验通俗题目

電針灸聯合標準療法治療難治性功能性消化不良：實況隨機對照試驗及經濟學評價

试验专业题目

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

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

联系人通讯地址

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临床试验信息

试验目的

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

试验分类

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试验类型

随机平行对照

试验分期

治疗新技术

随机化

Blocked randomization will be used to allocate patients to the two groups, with random block sizes.

盲法

Not Applicable

试验项目经费来源

Health andMedical Research Fund

试验范围

目标入组人数

132

实际入组人数

第一例入组时间

1990-01-01

试验终止时间

1990-01-01

是否属于一致性

入选标准

1. 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; 2. 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; 3. Voluntary discontinuation of any conventional pharmacological treatments for their functional dyspepsia 2 weeks prior to enrolment, due to perceived ineffectiveness; 4. Hong Kong permanent resident; 5. 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. 1. 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; 2. Current regular user of non-steroidal anti-inflammatory drugs, anti-depressants or anxiolytic drugs, as defined as daily use in the past 2 months; 3. Patients who had received major abdominal surgery; 4. Patients who are pregnant; 5. Patients who are wearing cardiac pacemaker; 6. Patients who are having underlying major physical illness such as malignancy and infections; 7. Patients are using any dose of PPIs or prokinetics two weeks prior to enrollment; 8. 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.；

研究者信息

研究负责人姓名

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试验机构

香港中文大學賽馬會公共衛生與基層醫療學院

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研究负责人邮编

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