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The effect of acupressure in treatment of Parkinson's disease (Non-motor symptoms): a pilot study.
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注册号：

Registration number：

 ChiCTR1900024795 

最近更新日期：

Date of Last Refreshed on：

 2019-07-27 21:33:18 

注册时间：

Date of Registration：

 2019-07-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

The effect of acupressure in treatment of Parkinson's disease (Non-motor symptoms): a pilot study.

Public title：

The effect of acupressure in treatment of Parkinson's disease (Non-motor symptoms): a pilot study.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

The effect of acupressure in treatment of Parkinson's disease (Non-motor symptoms): a pilot study.

Scientific title：

The effect of acupressure in treatment of Parkinson's disease (Non-motor symptoms): a pilot study.

研究课题代号(代码)：

Study subject ID：

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：

申请注册联系人：

Lai Hong Yi Justin 

研究负责人：

Prof Li Min 

Applicant：

Lai Hong Yi Justin 

Study leader：

Prof Li Min 

申请注册联系人电话：

Applicant telephone：

 +852 6393 0564

研究负责人电话：

Study leader's
telephone：

+852 3411 2481

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：

 justinlai14@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 limin@hkbu.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 http://cpdr.hkbu.edu.hk

申请注册联系人通讯地址：

Flat B, 5 Floor, 17 Chi Fuk Circuit, Fanling, New Territory, Hong Kong, China

研究负责人通讯地址：

4/F, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Kowloon Tong, Kowloon, Hong Kong, China

Applicant address：

Flat B, 5 Floor, 17 Chi Fuk Circuit, Fanling, New Territory, Hong Kong, China

Study leader's address：

4/F, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Kowloon Tong, Kowloon, Hong Kong, China

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：

香港浸會大學賽馬會中醫藥學院

Applicant's institution：

School of Chinese Medicine, Hong Kong Baptist University

研究负责人所在单位：

香港浸會大學賽馬會中醫藥學院

Affiliation of the Leader：

School of Chinese Medicine, Hong Kong Baptist University

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：

 REC/Student/18-19/0629

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：

Research Ethic Committee, Hong Kong Baptist University

Name of the ethic committee：

Research Ethic Committee, Hong Kong Baptist University

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-06-01 00:00:00

伦理委员会联系人：

Prof Rick Wong

Contact Name of the ethic committee：

Prof Rick Wong

伦理委员会联系地址：

AAB 904, Level 9, Academic and Administration Building, Baptist University Road Campus Hong Kong Baptist University, Kowloon Tong, Hong Kong, China

Contact Address of the ethic committee：

AAB 904, Level 9, Academic and Administration Building, Baptist University Road Campus Hong Kong Baptist University, Kowloon Tong, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3411 5127

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 hkbu_rec@hkbu.edu.hk

研究实施负责（组长）单位：

香港浸會大學中醫藥學院

Primary sponsor：

School of Chinese Medicine, Hong Kong Baptist University

研究实施负责（组长）单位地址：

香港九龍塘浸會大學道賽馬會中醫藥學院大樓

Primary sponsor's address：

Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Kowloon Tong, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

No funding

Source(s) of funding：

No funding.

研究疾病：

帕金森氏病  

Target disease：

Parkinson's disease

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

To evaluate the therapeutic effect of Chinese Medicine acupressure therapy on the Parkinson's disease (Non motor symptoms).  

Objectives of Study：

To evaluate the therapeutic effect of Chinese Medicine acupressure therapy on the Parkinson's disease (Non motor symptoms).

药物成份或治疗方案详述：

Participants in the treatment group will receive acupressure on specific acu-points for 8 weeks. The degree of non-motor symptoms will be assessed by the Non-motor symptom scale (NMSS), the deficiency of spleen Qi (DSQ) scale, and the Parkinson's Disease Questionnaire (Domain of mobility + activities of daily living) in week 0, 4,and 8. 

Description for medicine or protocol of treatment in detail：

Participants in the treatment group will receive acupressure on specific acu-points for 8 weeks. The degree of non-motor symptoms will be assessed by the Non-motor symptom scale (NMSS), the deficiency of spleen Qi (DSQ) scale, and the Parkinson's Disease Questionnaire (Domain of mobility + activities of daily living) in week 0, 4,and 8. 

纳入标准：

Inclusion criteria

排除标准：

(1) Atypical or secondary parkinsonism;
(2) Use of antidepressants during the preceding month;
(3) History of psychosis;
(4) Suicide attempts during the preceding 12 months;
(5) Severe diseases (i.e. cancer, stroke and acute present heart attack);
(6) Participating in other behavioural or pharmacological studies;
(7) Pregnancy or breast feeding;
(8) Surgery within preceding two months or having a scheduled operation within the period of study;
(9) Hoehn and Yahr (H&Y) stage >=4.

Exclusion criteria：

(1) Atypical or secondary parkinsonism;
(2) Use of antidepressants during the preceding month;
(3) History of psychosis;
(4) Suicide attempts during the preceding 12 months;
(5) Severe diseases (i.e. cancer, stroke and acute present heart attack);
(6) Participating in other behavioural or pharmacological studies;
(7) Pregnancy or breast feeding;
(8) Surgery within preceding two months or having a scheduled operation within the period of study;
(9) Hoehn and Yahr (H&Y) stage >=4.

研究实施时间：

Study execute time：

从 From 2018-12-01 00:00:00至 To 2020-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-08-12 00:00:00 至 To 2019-09-14 00:00:00

干预措施：

Interventions：

组别：

Experimental group

样本量：

 30

Group：

Experimental group

Sample size：

干预措施：

acupressure

干预措施代码：

Intervention：

acupressure

Intervention code：

组别：

Control group

样本量：

 30

Group：

Control

Sample size：

干预措施：

No treatment

干预措施代码：

Intervention：

No treatment

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：

Hong Kong

单位(医院)：

 香港浸會大學中醫藥學院 

单位级别：

 香港浸會大學中醫藥學院 

Institution
hospital：

Hong Kong Baptist University

Level of the institution：

School of Chinese Medicine

测量指标：

Outcomes：

指标中文名：

Change of Non-motor Symptoms scale

指标类型：

主要指标

Outcome：

Non-motor Symptoms scale

Type：

Primary indicator

测量时间点：

Week 0, 4, 8

测量方法：

Total score of the Non-motor Symptoms scale (NMSS)

Measure time point of outcome：

Week 0, 4, 8

Measure method：

Total score of the Non-motor Symptoms scale (NMSS)

指标中文名：

Change of Deficiency of Spleen Qi rating scale

指标类型：

次要指标

Outcome：

Deficiency of Spleen Qi rating scale

Type：

Secondary indicator

测量时间点：

Week 0, 4, 8

测量方法：

Total score of the Deficiency of Spleen Qi rating scale (DSQ)

Measure time point of outcome：

Week 0, 4, 8

Measure method：

Total score of the Deficiency of Spleen Qi rating scale (DSQ)

指标中文名：

Improvement of Parkinson's Disease symptoms

指标类型：

次要指标

Outcome：

Improvement of Parkinson's Disease symptoms

Type：

Secondary indicator

测量时间点：

Week 0, 4, 8

测量方法：

Total score of the Parkinson's Disease Questionnaire (Mobility + Activities of daily living)

Measure time point of outcome：

Week 0, 4, 8

Measure method：

Total score of the Parkinson's Disease Questionnaire (Mobility + Activities of daily living)

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 80 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）：

This procedure is conducted by Mr Chung Fat Yin, who is an individual research assistant. Each participant will receive a number randomly. Then, they will be randomly assigned into treatment group and control group by an Excel programme.

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

This procedure is conducted by Mr Chung Fat Yin, who is an individual research assistant. Each participant will receive a number randomly. Then, they will be randomly assigned into treatment group and control group by an Excel programme.

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：

Assessor blinding (1) Assessor blinding: Assessor will receive the number sequence of participant. Assessor will never know the identity of participant or which group he/she belong to.

Blinding：

Assessor blinding (1) Assessor blinding: Assessor will receive the number sequence of participant. Assessor will never know the identity of participant or which group he/she belong to.

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

是Yes

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）：

The original data will be uploaded to ResMan original data sharing platform within 6 months after the completion of the trial.

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

The original data will be uploaded to ResMan original data sharing platform within 6 months after the completion of the trial.

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：

The data were collected and managed with the CRF and electronic management systems

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

The data were collected and managed with the CRF and electronic management systems

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2019-07-27 21:33:18
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