ChiCTR-IPC-15007109 版本V2.2 版本创建时间2017/06/22 21:08:49 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR-IPC-15007109 

最近更新日期：

Date of Last Refreshed on：

 2017-06-19 21:27:40 

注册时间：

Date of Registration：

 2015-09-18 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

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

Public title：

Electroacupuncture plus on-demand gastrocaine versus waiting list plus on-demand gastrocaine for functional dyspepsia: A pragmatic randomized trial with economic evaluation

注册题目简写：

English Acronym：

研究课题的正式科学名称：

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

Scientific title：

Electroacupuncture plus on-demand gastrocaine versus waiting list plus on-demand gastrocaine for functional dyspepsia: A pragmatic randomized trial with economic evaluation

研究课题代号(代码)：

Study subject ID：

 2014.552-T

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

CUHK_CCRB00478

申请注册联系人：

Vincent Chi Ho, Chung 

研究负责人：

Vincent Chi Ho, Chung 

Applicant：

Vincent Chi Ho, Chung 

Study leader：

Vincent Chi Ho, Chung 

申请注册联系人电话：

Applicant telephone：

 +852 2252-8453

研究负责人电话：

Study leader's
telephone：

+852 2252-8453

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 vchung@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 vchung@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 https://www2.ccrb.cuhk.edu.hk/registry/public/322

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 https://www2.ccrb.cuhk.edu.hk/registry/public/322

申请注册联系人通讯地址：

4/F, School of Public Health andPrimary Care, Prince of Wales Hospital, Shatin, Hong Kong

研究负责人通讯地址：

4/F, School of Public Health andPrimary Care, Prince of Wales Hospital, Shatin, Hong Kong

Applicant address：

4/F, School of Public Health andPrimary Care, Prince of Wales Hospital, Shatin, Hong Kong

Study leader's address：

4/F, School of Public Health andPrimary Care, Prince of Wales Hospital, Shatin, Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

JC School of Public Health and Primary Care, The Chinese University of Hong Kong

Applicant's institution：

JC School of Public Health and Primary Care, The Chinese University of Hong Kong

研究负责人所在单位：

JC School of Public Health and Primary Care, The Chinese University of Hong Kong

Affiliation of the Leader：

JC School of Public Health and Primary Care, The Chinese University of Hong Kong

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2014.552-T

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

Joint CUHK-NTEC Clinical Research Ethics Committee

Name of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2015-08-24 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

JC School of Public Health and Primary Care, The Chinese University of Hong Kong

Primary sponsor：

JC School of Public Health and Primary Care, The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

JC School of Public Health and Primary Care, The Chinese University of Hong Kong

Primary sponsor's address：

JC School of Public Health and Primary Care, The Chinese University of Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

Integrative Medical Centre (IMC), Faculty of Medicine, The Chinese University of Hong Kong

具体地址：

Integrative Medical Centre (IMC), Faculty of Medicine, The Chinese University of Hong Kong

Institution
hospital：

Integrative Medical Centre (IMC), Faculty of Medicine, The Chinese University of Hong Kong

Address：

Integrative Medical Centre (IMC), Faculty of Medicine, The Chinese University of Hong Kong

经费或物资来源：

Health andMedical Research Fund

Source(s) of funding：

Health andMedical Research Fund

研究疾病：

功能性消化不良  

Target disease：

Functional Dyspepsia (FD)

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

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  

Objectives of Study：

To compare the effectiveness and cost effectiveness of electroacupuncture (EA) plus on-demand gastrocaine with waiting list for EA plus on-demand gastrocaine in providing symptom relief and quality of life improvement among FD patients.

药物成份或治疗方案详述：

Experimental group: 20 sessions of Electroacupuncture (EA) over 10 weeks plus on-demand gastrocaine, 30 minutes EA/ Each tablet [Oxethazaine 5 mg, Al(OH)3 dried gel 126 mg, Mg(OH)2 100 mg], 2 sessions per week/ Up to 4 tablets a day, 10 weeks. Control group: Waiting list to EA plus on-demand Gastrocaine: On-demand gastrocaine and being nominated on to a waiting list for EA, which entitles 20 sessions of EA over 10 weeks after 12 weeks of waiting. Each tablet [Oxethazaine 5 mg, Al(OH)3 dried gel 126 mg, Mg(OH)2 100 mg], Up to 4 tablets a day, 10 weeks. 

Description for medicine or protocol of treatment in detail：

Experimental group: 20 sessions of Electroacupuncture (EA) over 10 weeks plus on-demand gastrocaine, 30 minutes EA/ Each tablet [Oxethazaine 5 mg, Al(OH)3 dried gel 126 mg, Mg(OH)2 100 mg], 2 sessions per week/ Up to 4 tablets a day, 10 weeks. Control group: Waiting list to EA plus on-demand Gastrocaine: On-demand gastrocaine and being nominated on to a waiting list for EA, which entitles 20 sessions of EA over 10 weeks after 12 weeks of waiting. Each tablet [Oxethazaine 5 mg, Al(OH)3 dried gel 126 mg, Mg(OH)2 100 mg], Up to 4 tablets a day, 10 weeks. 

纳入标准：

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. Hong Kong permanent resident;
4. Aged 18 – 70 years.

Inclusion criteria

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. Hong Kong permanent resident;
4. Aged 18 – 70 years.

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.

Exclusion criteria：

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.

研究实施时间：

Study execute time：

从 From 1990-01-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2015-12-10 00:00:00 至 To 2018-12-31 00:00:00

干预措施：

Interventions：

组别：

Two groups

样本量：

 132

Group：

Two groups

Sample size：

干预措施：

Electroacupuncture (EA) plus on-demand gastrocaine versus Waiting list to EA plus on-demand Gastrocaine

干预措施代码：

Intervention：

Electroacupuncture (EA) plus on-demand gastrocaine versus Waiting list to EA plus on-demand Gastrocaine

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 JC School of Public Health andPrimary Care, The Chinese University of Hong Kong 

单位级别：

 JC School of Public Health andPrimary Care, The Chinese University of Hong Kong 

Institution
hospital：

JC School of Public Health andPrimary Care, The Chinese University of Hong Kong

Level of the institution：

JC School of Public Health andPrimary Care, The Chinese University of Hong Kong

测量指标：

Outcomes：

指标中文名：

Binary assessment of adequate relief as primary endpoint

指标类型：

主要指标

Outcome：

Binary assessment of adequate relief as primary endpoint

Type：

Primary indicator

测量时间点：

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.

测量方法：

The outcome will be assessed by a weekly question of “in the past 7 days, have you had adequate relief of your upper abdominal pain or discomfort? (Yes / No)”.

Measure time point of outcome：

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.

Measure method：

The outcome will be assessed by a weekly question of “in the past 7 days, have you had adequate relief of your upper abdominal pain or discomfort? (Yes / No)”.

指标中文名：

Nepean Dyspepsia Index (NDI)

指标类型：

次要指标

Outcome：

Nepean Dyspepsia Index (NDI)

Type：

Secondary indicator

测量时间点：

Assessment of the outcome will be performed at baseline and 12th week.

测量方法：

For symptom checklist, simple addition of the frequency, severity and bothersomeness items to create a total score; Four 0 to 100 point subscales to measure Interference, Knowledge/control, Eating/ drinking and Sleep

Measure time point of outcome：

Assessment of the outcome will be performed at baseline and 12th week.

Measure method：

For symptom checklist, simple addition of the frequency, severity and bothersomeness items to create a total score; Four 0 to 100 point subscales to measure Interference, Knowledge/control, Eating/ drinking and Sleep

指标中文名：

Patient Health Questionnaire 9 (PHQ9)

指标类型：

次要指标

Outcome：

Patient Health Questionnaire 9 (PHQ9)

Type：

Secondary indicator

测量时间点：

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.

测量方法：

A point range of 0 to 27

Measure time point of outcome：

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.

Measure method：

A point range of 0 to 27

指标中文名：

Patient Health Questionnaire section for Anxiety (GAD7)

指标类型：

次要指标

Outcome：

Patient Health Questionnaire section for Anxiety (GAD7)

Type：

Secondary indicator

测量时间点：

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.

测量方法：

A point range of 0 to 21

Measure time point of outcome：

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.

Measure method：

A point range of 0 to 21

指标中文名：

Nutrient Drink Test (NDT)

指标类型：

次要指标

Outcome：

Nutrient Drink Test (NDT)

Type：

Secondary indicator

测量时间点：

Assessment of the outcome will be performed at baseline and 12th week.

测量方法：

Four 0 to 100 point subscales to measure Nausea, Bloating, Pain and Fullness

Measure time point of outcome：

Assessment of the outcome will be performed at baseline and 12th week.

Measure method：

Four 0 to 100 point subscales to measure Nausea, Bloating, Pain and Fullness

指标中文名：

Adverse Events Questionnaire

指标类型：

次要指标

Outcome：

Adverse Events Questionnaire

Type：

Secondary indicator

测量时间点：

Adverse events (AE) will be monitored at weekly interval over 12 weeks via phone interview.

测量方法：

Have you experienced any symptoms which you think might be caused by your electroacupuncture treatment/ Gastrocaine? (Yes/No). If yes, please describe. How likely do you think it is the acupuncture procedure/ Gastrocaine that caused these symptoms? (Definitely /Probably /Possibly /Unlikely).

Measure time point of outcome：

Adverse events (AE) will be monitored at weekly interval over 12 weeks via phone interview.

Measure method：

Have you experienced any symptoms which you think might be caused by your electroacupuncture treatment/ Gastrocaine? (Yes/No). If yes, please describe. How likely do you think it is the acupuncture procedure/ Gastrocaine that caused these symptoms? (Definitely /Probably /Possibly /Unlikely).

指标中文名：

EuroQol (EQ-5D) questionnaire to estimate Quality-adjusted life-years (QALYs) gained

指标类型：

次要指标

Outcome：

EuroQol (EQ-5D) questionnaire to estimate Quality-adjusted life-years (QALYs) gained

Type：

Secondary indicator

测量时间点：

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.

测量方法：

Five levels of perceived problems in Mobility, Self-care, Usual activities, Pain/ discomfort and Anxiety/ depression; A visual analogue scale with a point range of 0 to 100

Measure time point of outcome：

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.

Measure method：

Five levels of perceived problems in Mobility, Self-care, Usual activities, Pain/ discomfort and Anxiety/ depression; A visual analogue scale with a point range of 0 to 100

指标中文名：

Patient reported change in individual symptoms

指标类型：

次要指标

Outcome：

Patient reported change in individual symptoms

Type：

Secondary indicator

测量时间点：

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.

测量方法：

Changes in postpradinal fullness, early satiety, epigastric pain, epigastric burning, and postprandial nausea measured on a 5 point Likert scale (absent, very mild or mild, moderate, severe, very severe) can be measured.

Measure time point of outcome：

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.

Measure method：

Changes in postpradinal fullness, early satiety, epigastric pain, epigastric burning, and postprandial nausea measured on a 5 point Likert scale (absent, very mild or mild, moderate, severe, very severe) can be measured.

指标中文名：

Patient reported change in global symptoms

指标类型：

次要指标

Outcome：

Patient reported change in global symptoms

Type：

Secondary indicator

测量时间点：

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.

测量方法：

Using a 7-point Likert scale (symptoms-free, marked improvement, slight improvement, no improvement, slight deterioration, marked deterioration, severe deterioration), patients are asked to assess the change in global symptoms.

Measure time point of outcome：

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.

Measure method：

Using a 7-point Likert scale (symptoms-free, marked improvement, slight improvement, no improvement, slight deterioration, marked deterioration, severe deterioration), patients are asked to assess the change in global symptoms.

指标中文名：

Direct medical cost associated with the management of FD

指标类型：

次要指标

Outcome：

Direct medical cost associated with the management of FD

Type：

Secondary indicator

测量时间点：

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.

测量方法：

Hong Kong dollars

Measure time point of outcome：

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.

Measure method：

Hong Kong dollars

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 70 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

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

Randomization Procedure (please state who generates the random number sequence and by what method)：

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

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Not Applicable

Blinding：

Not Applicable

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

Not stated

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Not stated

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

Not stated

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Not stated

数据与安全监察委员会：

Data and Safety Monitoring Committee：

注册人：

Name of Registration：

  2015-09-20 12:32:58