ChiCTR-IPR-17013088 版本V1.0 版本创建时间2017/10/23 23:36:19 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-IPR-17013088 

最近更新日期：

Date of Last Refreshed on：

2017-10-23 23:34:23 

注册时间：

Date of Registration：

2017-10-23 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

莊智元医师：此表未填完，缺征募参试者日期 Clinical study of localized Tui Na combination with points press in reducing the symptoms of knee stiffness in Parkins

Public title：

Clinical study of localized Tui Na combination with points press in reducing the symptoms of knee stiffness in Parkinson 's disease: A Randomized Pilot Clinical Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Clinical study of localized Tui Na combination with points press in reducing the symptoms of knee stiffness in Parkinson 's disease: A Randomized Pilot Clinical Trial

Scientific title：

Clinical study of localized Tui Na combination with points press in reducing the symptoms of knee stiffness in Parkinson 's disease: A Randomized Pilot Clinical Trial

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：

莊智元 

研究负责人：

Professor Li Min 

Applicant：

Zhuang Zhiyuan 

Study leader：

Professor Li Min 

申请注册联系人电话：

Applicant telephone：

+852 66163749

研究负责人电话：

Study leader's telephone：

+852 34112919

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：

zhuangzhou94@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)：

申请注册联系人通讯地址：

中國香港特別行政區九龍塘浸會大學道7號

研究负责人通讯地址：

中國香港特別行政區九龍塘浸會大學道7號

Applicant address：

7 Baptist University Road, Kolong Tang, Hong Kong SAR, China

Study leader's address：

7 Baptist University Road, Kolong Tang, Hong Kong SAR, 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：

香港浸會大學中醫藥學院

Applicant's institution：

Hong Kong Baptist University School of Chinese Medicine

研究负责人所在单位：

香港浸會大學中醫藥學院

Affiliation of the Leader：

Hong Kong Baptist University School of Chinese Medicine

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

HASC/Student/16-17/631

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

HONG KONG BAPTIST UNIVERSITY Committee on the Use of Human & Animal Subjects in Teaching & Research

Name of the ethic committee：

HONG KONG BAPTIST UNIVERSITY Committee on the Use of Human & Animal Subjects in Teaching & Research

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：

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：

香港浸會大學中醫藥學院

Primary sponsor：

Hong Kong Baptist University School of Chinese Medicine

研究实施负责（组长）单位地址：

中國香港特別行政區九龍塘浸會大學道7號

Primary sponsor's address：

7 Baptist University Road, Kolong Tang, Hong Kong SAR, China

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)：

香港浸會大學中醫藥學院

具体地址：

中國香港特別行政區九龍塘浸會大學道7號

Institution
hospital：

Hong Kong Baptist University School of Chinese Medicine

Address：

7 Baptist University Road, Kolong Tang, Hong Kong SR, China

经费或物资来源：

Student Honors Project Funding

Source(s) of funding：

Student Honors Project Funding

Target disease：

Parkinson’s disease (PD)

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：

i. To evaluate the efficacy of localized Tui Na combining with points press (Abbreviated as LTNCPP) in reducing the motor symptoms of PD especially focusing on releasing lower limbs movement barriers and muscles dysfunction; ii. To evaluate the safety of LTNCPP in subjects with idiopathic PD in a randomized clinical trial.  

Objectives of Study：

i. To evaluate the efficacy of localized Tui Na combining with points press (Abbreviated as LTNCPP) in reducing the motor symptoms of PD especially focusing on releasing lower limbs movement barriers and muscles dysfunction; ii. To evaluate the safety of LTNCPP in subjects with idiopathic PD in a randomized clinical trial.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Patients will be included if they have all the following:
1. Meet UKPDBB criteria;
2. Age of 18 to 80 years (inclusive);
3. have the symptoms of LLMB;
4. Stable treatment with levodopa, alone or in combination with other antiparkinsonian drugs or any other treatment over the last 2 months;
5. does not have any bone fractures or operation history over last half year.

Inclusion criteria

Patients will be included if they have all the following:
1. Meet UKPDBB criteria;
2. Age of 18 to 80 years (inclusive);
3. have the symptoms of LLMB;
4. Stable treatment with levodopa, alone or in combination with other antiparkinsonian drugs or any other treatment over the last 2 months;
5. does not have any bone fractures or operation history over last half year.

排除标准：

Patients will be excluded if they have one or more of the following:
1. Atypical or secondary Parkinsonism;
2. with any other severe diseases (i.e. cancer and acute present asthma);
3. operation history or trauma history over last half year;
4. Pregnancy or are breast feeding.

Exclusion criteria：

Patients will be excluded if they have one or more of the following:
1. Atypical or secondary Parkinsonism;
2. with any other severe diseases (i.e. cancer and acute present asthma);
3. operation history or trauma history over last half year;
4. Pregnancy or are breast feeding.

研究实施时间：

Study execute time：

从 From 2017-04-01 00:00:00至 To 2018-01-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2017-10-31 00:00:00 至 To 2017-11-07 00:00:00  

干预措施：

Interventions：

组别：

Treatment Group

样本量：

20

Group：

Treatment Group

Sample size：

干预措施：

4 times free Tui Na service(LTNCPP)

干预措施代码：

Intervention：

4 times free Tui Na service(LTNCPP)

Intervention code：

组别：

Control group

样本量：

20

Group：

Control group

Sample size：

干预措施：

join the health talks about PD

干预措施代码：

Intervention：

join the health talks about PD

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)：

香港浸會大學中醫藥學院 

单位级别：

Clinics Laboratory 

Institution
hospital：

one of the Chinese Medicine clinics laboratory of the Hong Kong Baptist University

Level of the institution：

Clinics Laboratory

测量指标：

Outcomes：

指标中文名：

Parkinson's Disease Questionnaire (PDQ-39)

指标类型：

主要指标

Outcome：

Parkinson's Disease Questionnaire (PDQ-39)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

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 30 岁 years
最大 Max age 90 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）：

A random number sequence will be generated with computer by Co-investigator (Co II), kept in a sealed envelope, and sent to Viven Law in Hong Kong.

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

A random number sequence will be generated with computer by Co-investigator (Co II), kept in a sealed envelope, and sent to Viven Law in Hong Kong.

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：

Blinding：

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

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）：

Through the publication of academic articles

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

Through the publication of academic articles

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：

Questionnaires and symptoms access records for special cases.

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

Questionnaires and symptoms access records for special cases.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2017-10-23 23:34:23