ChiCTR-TRC-13003085 版本V1.0 版本创建时间2016/1/26 19:49:59 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-TRC-13003085 

最近更新时间:

Date of Last Refreshed on:

2015/5/5 10:41:19 

注册号状态:

预注册  

Registration Status:

Prospective registration  

填写语言:

仅英文  

Language:

English Only  

注册题目:

 

Public title:

The effect of Chinese Herbal Medicine (JiaWeiLiuJunZiTang) on Non-motor Symptoms in Idiopathic Parkinson’s Disease (PD): A Randomized Controlled Trial 

注册题目简写:

 

Public title acronym:

 

研究课题的正式科学名称:

 

Scientific title:

The effect of Chinese Herbal Medicine (JiaWeiLiuJunZiTang) on Non-motor Symptoms in Idiopathic Parkinson’s Disease (PD): A Randomized Controlled Trial 

研究课题的正式科学名称简写:

 

Scientific title acronym:

 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

 

研究负责人:

 

Applicant:

Chua Ka Kit 

Study leader:

Li Min 

申请注册联系人电话:

Applicant telephone:

+852 67008538 

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:

kyo1212hk@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

bucmpd@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:

 

研究负责人通讯地址:

 

Applicant address:

Flat D1, 8/F, 26 Kam Ping St, North Point, Hong Kong 

Study leader's address:

School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, 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:

 

Applicant's institution:

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:

HASC/09-10/09 

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:

 

Name of the ethic committee:

Hong Kong Baptist University committee on the use of human & animal subjects in teaching and research (HASC) 

伦理委员会批准日期:

Date of approved by ethic committee:

2009-11-11 

国家FDA批准文号:

Approved No. of SFDA:

国家FDA批准附件:

Approved file of SFDA:

国家FDA批准日期:

Date of approved by SFDA:

研究实施负责(组长)单位:

 

Primary sponsor:

Food and Health Bureau, Hong Kong S.A.R. 

研究实施负责(组长)单位地址:

 

Primary sponsor's address:

Scientific Review Director of the Food and Health Bureau at 18/F, Murray Building, Garden Road, Hong Kong 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

省(直辖市):

市(区县):

Country:

China

Province:

Hong Kong SAR

City:

单位(医院):

具体地址:

Institution
hospital:

Hong Kong Baptist Univesity

Address:

Hong Kong Baptist Univesity

经费或物资来源:

 

Source(s) of funding:

Health and Health Services Research Fund 

研究疾病:

 

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:

I期临床试验 

Study phase:

研究目的:

 

Objectives of Study:

To evaluate the efficacy JWLJZT for the treatment of NMS of PD; To evaluate the safety of JWLJZT in subjects with idiopathic PD. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

 

Inclusion criteria

Patients will be included if they have all the following: a. Meet UKPDBB criteria; b. Age of 18 to 80 years (inclusive); c. Meet the diagnosis of DSQ; d. Stable treatment with levodopa, alone or in combination with other antiparkinsonian drugs over the last 2 months; e. A PD rating of 1.5 to 4 on the Modified Hoehn and Yahr scale; f. Normal liver and renal function in blood test. 

排除标准:

 

Exclusion criteria:

Patients will be excluded if they have one or more of the following: a. Atypical or secondary Parkinsonism; b. Use of antidepressants during the preceding month; c. History of psychosis; d. Suicide attempts during the preceding 12 months, or a severe suicidal tendency (score ≧ 3 on HAM-D item 3, suicide); e. Mini-Mental State Examination (MMSE) < 24; f. Severe diseases (i.e. cancer and acute present asthma); f. Allergy to Chinese herbal medicine; g. Pregnancy or are breast feeding. 

研究实施时间:

Study execute time:

From2011-10-31To 2014-10-31 

干预措施:

Interventions:

组别:

样本量:

122

Group:

Treatment

Sample size:

干预措施:

干预措施代码:

Intervention:

JWLJZT + routine western medications

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

指标类型:

主要指标 

Outcome:

NMSS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

主要指标 

Outcome:

MDS-UPDRS part

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

次要指标 

Outcome:

PDQ-39

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

次要指标 

Outcome:

DSQ

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

次要指标 

Outcome:

MDS-UPDRS part 2-4

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

次要指标 

Outcome:

SF-36

Type:

Secondary 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:

标本中文名:

组织:

Sample Name:

Saliva

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

组织:

Sample Name:

Urine

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

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 40 years
最大 Max age 79 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

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

Stratified blocked randomization is used. It is according to the H & Y stage (I-IV). For detail, ple

UTN(全球唯一识别码):

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

Data collection Institution:

资料管理单位:

Data management Institution:

资料分析单位:

Data analysis Institution:

注册人:

Name on Registration:

 2013-02-28