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Water extract of Gastrodiae Rhizoma as a supplement for refractory epilepsy: a translation of basic research to clinical practice
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注册号:

Registration number:

ChiCTR1800015349 

最近更新日期:

Date of Last Refreshed on:

2018-03-25 

注册时间:

Date of Registration:

2018-03-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

使用天麻水提物紓緩惡性難治腦癇症患者的發作情況 

Public title:

Water extract of Gastrodiae Rhizoma as a supplement for refractory epilepsy: a translation of basic research to clinical practice 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

使用天麻水提物紓緩惡性難治腦癇症患者的發作情況 

Scientific title:

Water extract of Gastrodiae Rhizoma as a supplement for refractory epilepsy: a translation of basic research to clinical practice 

研究课题代号(代码):

Study subject ID:

Protocol no. 2018-HL-001 

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_CCRB00596 

申请注册联系人:

Ka Lai Yip 

研究负责人:

Ho Wan Leung 

Applicant:

Ka Lai Yip 

Study leader:

Ho Wan Leung 

申请注册联系人电话:

Applicant telephone:

+852 3505 3856 

研究负责人电话:

Study leader's telephone:

+852 35053856 

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:

Hannahykl@cuhk.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

Howanleung@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/527 

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/527 

申请注册联系人通讯地址:

Room 124010, 10/F, Lui Che Woo Clinical Sciences Building, Price of Wales Hospital, 30-32 Ngan Shing Street, Shatin, New Territories, Hong Kong, China 

研究负责人通讯地址:

Division of Neurology, Department of Medicine & Therapeutics, Price of Wales Hospital, Shatin, Hong Kong, China 

Applicant address:

Room 124010, 10/F, Lui Che Woo Clinical Sciences Building, Price of Wales Hospital, 30-32 Ngan Shing Street, Shatin, New Territories, Hong Kong, China 

Study leader's address:

Division of Neurology, Department of Medicine & Therapeutics, Price of Wales Hospital, Shatin, 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:

Division of Neurology, The Chinese University of Hong Kong 

Applicant's institution:

Division of Neurology, 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:

CREC Ref. No: 2018.004 

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:

2018-03-05 

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:

The Chinese University of Hong Kong 

Primary sponsor:

The Chinese University of Hong Kong 

研究实施负责(组长)单位地址:

The Chinese University of Hong Kong 

Primary sponsor's address:

The Chinese University of 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:

N/A 

Source(s) of funding:

N/A 

研究疾病:

惡性難治腦癇症 

Target disease:

refractory epilepsy 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

使用天麻水提物紓緩惡性難治腦癇症患者的發作情況 

Objectives of Study:

Water extract of Gastrodiae Rhizoma as a supplement for refractory epilepsy 

药物成份或治疗方案详述:

A prospective design is adopted for subject recruitment. The present study is randomized, open-label and placebo-controlled clinical trial for adopting the water extract of Gastrodiae Rhizoma for refractory epilepsy subjects. This study will collect information about demographic details, medical history and whole blood. The seizure information will collect based on subjects’seizure diary (electronic available on personal cell phone or written version provided by Hong Kong Epilepsy Society). Clinical assessments will be done with subjects and/or with their care-givers by face-to-face interview. The EEG signals, laboratory results and other relevant information will also be collected. 

Description for medicine or protocol of treatment in detail:

A prospective design is adopted for subject recruitment. The present study is randomized, open-label and placebo-controlled clinical trial for adopting the water extract of Gastrodiae Rhizoma for refractory epilepsy subjects. This study will collect information about demographic details, medical history and whole blood. The seizure information will collect based on subjectsseizure diary (electronic available on personal cell phone or written version provided by Hong Kong Epilepsy Society). Clinical assessments will be done with subjects and/or with their care-givers by face-to-face interview. The EEG signals, laboratory results and other relevant information will also be collected. 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

1. Subject aged 18 years or above; 2. Subject has a diagnosis of refractory epilepsy; 3. Persistent seizures despite sequential or add-on therapy with 2 or more antiepileptic drugs 4. At least one or more non-seizure symptoms including and not limited to dizziness, vertigo, headache, insomnia, cognitive impairment and behavioural problem; 5. Subject able to speak and listen Chinese. 

Inclusion criteria

1. Subject aged 18 years or above; 2. Subject has a diagnosis of refractory epilepsy; 3. Persistent seizures despite sequential or add-on therapy with 2 or more antiepileptic drugs 4. At least one or more non-seizure symptoms including and not limited to dizziness, vertigo, headache, insomnia, cognitive impairment and behavioural problem; 5. Subject able to speak and listen Chinese. 

排除标准:

1. Abnormal renal and liver functions at baseline; 2. Concomitant antipsychotic drugs or serotonin-reuptake inhibitors; 3. Substance abuse; 4. Pregnancy or breastfeeding; 5. Active history of malignancy; 6. Unwillingness to give consent for herbal supplementation with GR by the subject or the care-taker of the subject; 7. Neurodegenerative conditions with predicted survival less than 6 months; 8. Active history of cardiovascular conditions. 

Exclusion criteria:

1. Abnormal renal and liver functions at baseline; 2. Concomitant antipsychotic drugs or serotonin-reuptake inhibitors; 3. Substance abuse; 4. Pregnancy or breastfeeding; 5. Active history of malignancy; 6. Unwillingness to give consent for herbal supplementation with GR by the subject or the care-taker of the subject; 7. Neurodegenerative conditions with predicted survival less than 6 months; 8. Active history of cardiovascular conditions. 

研究实施时间:

Study execute time:

FromTo  

干预措施:

Interventions:

组别:

Two groups

样本量:

120

Group:

Two groups

Sample size:

干预措施:

Herbal supplement Powder 4.5 grams daily, once per day, 12 weeks versus Placebo treatment without bio-active ingredients

干预措施代码:

Intervention:

Herbal supplement Powder 4.5 grams daily, once per day, 12 weeks versus Placebo treatment without bio-active ingredients

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):

The Chinese University of Hong Kong 

单位级别:

The Chinese University of Hong Kong 

Institution
hospital:

The Chinese University of Hong Kong  

Level of the institution:

The Chinese University of Hong Kong 

测量指标:

Outcomes:

指标中文名:

Seizure-freedom

指标类型:

主要指标 

Outcome:

Seizure-freedom

Type:

Primary indicator 

测量时间点:

12 weeks

测量方法:

The day of achieving seizure-freedom will be recorded in baseline, maintenance and treatment phases

Measure time point of outcome:

12 weeks

Measure method:

The day of achieving seizure-freedom will be recorded in baseline, maintenance and treatment phases

指标中文名:

Seizure frequency

指标类型:

主要指标 

Outcome:

Seizure frequency

Type:

Primary indicator 

测量时间点:

12 weeks

测量方法:

50% responder rate will be calculated according to seizure frequency in baseline, maintenance phase. It is defined as the number of subjects achieving more than 50% reduction in seizure counts over the maintenance period.

Measure time point of outcome:

12 weeks

Measure method:

50% responder rate will be calculated according to seizure frequency in baseline, maintenance phase. It is defined as the number of subjects achieving more than 50% reduction in seizure counts over the maintenance period.

指标中文名:

Tolerailibilty

指标类型:

次要指标 

Outcome:

Tolerailibilty

Type:

Secondary indicator 

测量时间点:

12 weeks

测量方法:

The behavioural disturbances effect will be recorded by Neuropsychiatric Inventory Questionnaire.

Measure time point of outcome:

12 weeks

Measure method:

The behavioural disturbances effect will be recorded by Neuropsychiatric Inventory 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 years
最大 Max age 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):

Non-randomized

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

Non-randomized

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-03-15
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