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

Registration number：

 ChiCTR1900025889 

最近更新日期：

Date of Last Refreshed on：

 2019-09-12 21:58:10 

注册时间：

Date of Registration：

 2019-09-12 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

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

Public title：

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

Scientific title：

The effect of TCM tuina 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：

Chung Fat Yin 

研究负责人：

Prof. LI Min 

Applicant：

Chung Fat Yin 

Study leader：

Prof. LI Min 

申请注册联系人电话：

Applicant telephone：

 +852 64956339

研究负责人电话：

Study leader's
telephone：

+852 3411 5387

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

 +852 3411 2902

申请注册联系人电子邮件：

Applicant E-mail：

 15217477@life.hkbu.edu.hk

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)：

申请注册联系人通讯地址：

Rm1421, Tak Man House, Oi Man Estate, Homantin, KLN, Hong Kong, China

研究负责人通讯地址：

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

Applicant address：

Rm1421, Tak Man House, Oi Man Estate, Homantin, KLN, Hong Kong, China

Study leader's address：

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：

CMTR, SCM, HKBU

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：

CMTR, SCM, HKBU

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/18-19/0630

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：

香港浸會大學賽馬會中醫藥學院臨床研究倫理委員會

Name of the ethic committee：

Research Ethics Committee (REC), Graduate School, Hong Kong Baptist University

伦理委员会批准日期：

Date of approved by ethic committee：

 1990-01-01 00:00:00

伦理委员会联系人：

臨床研究倫理委員會

Contact Name of the ethic committee：

Research Ethics Committee (REC)

伦理委员会联系地址：

香港九龍塘浸會大學道賽馬會中醫藥學院大樓

Contact Address of the ethic committee：

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

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：

 15217477@life.hkbu.edu.hk

研究实施负责（组长）单位：

香港浸會大學道賽馬會中醫藥學院

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, Kowloon

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 effect of traditional Chinese medicine tuina in treating the non-motor symptoms of Parkinson's Disease.  

Objectives of Study：

To evaluate the effect of traditional Chinese medicine tuina in treating the non-motor symptoms of Parkinson's Disease.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

Participants in the treatment group will receive TCM tuina on specific acu-points and meridians for 8 weeks. The degree of non-motor symptoms will be assessed by the Non-motor symptom scale (NMSS) and the DSQ scale 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 beast feeding;
(8) Surgery within preceding two months or having a scheduled operation within the period of study; or
(9) Hoehn and Yahr (H&Y) stage ≧4, with activities limited to wheelchairs.

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 beast feeding;
(8) Surgery within preceding two months or having a scheduled operation within the period of study; or
(9) Hoehn and Yahr (H&Y) stage ≧4, with activities limited to wheelchairs.

研究实施时间：

Study execute time：

从 From 2019-10-21 00:00:00至 To 2020-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-09-30 00:00:00 至 To 2019-10-13 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 30

Group：

Experimental group

Sample size：

干预措施：

TCM tuina

干预措施代码：

Intervention：

TCM tuina

Intervention code：

组别：

对照组

样本量：

 30

Group：

Control

Sample size：

干预措施：

Observation

干预措施代码：

Intervention：

Observation

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：

HKSAR

City：

Hong Kong

单位(医院)：

 香港浸會大學道賽馬會中醫藥學院 

单位级别：

 大学 

Institution
hospital：

School of Chinese Medicine, Hong Kong Baptist University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Total score of the Non-Motor Symptom Scale (NMSS)

指标类型：

主要指标

Outcome：

Total score of the Non-Motor Symptom Scale (NMSS)

Type：

Primary indicator

测量时间点：

Weeks 0,4,8

测量方法：

Questionnaire

Measure time point of outcome：

Weeks 0,4,8

Measure method：

Questionnaire

指标中文名：

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

指标类型：

次要指标

Outcome：

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

Type：

Secondary indicator

测量时间点：

Weeks 0,4,8

测量方法：

Questionnaire

Measure time point of outcome：

Weeks 0,4,8

Measure method：

Questionnaire

指标中文名：

Total score of MDS-UPDRS

指标类型：

次要指标

Outcome：

Total score of MDS-UPDRS

Type：

Secondary indicator

测量时间点：

Weeks 0,4,8

测量方法：

Questionnaire

Measure time point of outcome：

Weeks 0,4,8

Measure method：

Questionnaire

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet 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 Lai Hong Yi Justin, 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 Lai Hong Yi Justin, 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：

  2019-09-12 21:58:10
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