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Effect of Xuefu Zhuyu Oral Liquid on Tension-Type Headache with Qi-Stagnation and Blood-Stasis Pattern: a Randomized Controlled Trial and an Observational Study for Tension-Type Headache with non Qi-Stagnation and Blood-Stasis Pattern
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注册号:

Registration number:

ChiCTR1900026716 

最近更新日期:

Date of Last Refreshed on:

2021-09-13 

注册时间:

Date of Registration:

2019-10-19 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

血府逐瘀口服液治疗紧张型头痛气滞血瘀证的随机对照试验及紧张型头痛非气滞血瘀证的观察性研究 

Public title:

Effect of Xuefu Zhuyu Oral Liquid on Tension-Type Headache with Qi-Stagnation and Blood-Stasis Pattern: a Randomized Controlled Trial and an Observational Study for Tension-Type Headache with non Qi-Stagnation and Blood-Stasis Pattern 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于“篮式设计”的两种中药经典名方上市后“以证统病”研究 

Scientific title:

Postmarket Research for Two Classical Formulae of Chinese Medicine Based on an Overarching Design 

研究课题代号(代码):

Study subject ID:

2018YFC1707407 

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:

周莉 

研究负责人:

温泽淮 

Applicant:

Li Zhou 

Study leader:

Zehuai Wen 

申请注册联系人电话:

Applicant telephone:

+86 13580393379 

研究负责人电话:

Study leader's telephone:

+86 20-81887233-35837 

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:

13580393379@139.com 

研究负责人电子邮件:

Study leader's E-mail:

13903008091@139.com 

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:

广州市越秀区大德路111号 

研究负责人通讯地址:

广州市越秀区大德路111号 

Applicant address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China 

Study leader's address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

510120 

研究负责人邮政编码:

Study leader's postcode:

510120 

申请人所在单位:

广州中医药大学第二附属医院(广东省中医院) 

Applicant's institution:

The Second Affiliated Hospital of Guangzhou University of Chinese medicine (Guangdong Provincial Hospital of Chinese Medicine) 

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:

广东省中医院伦理委员会BF2019-175-01 

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:

广东省中医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Guangdong Provincial Hospital of Chinese Mdeicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-09-27 

伦理委员会联系人:

李晓彦 

Contact Name of the ethic committee:

Xiaoyan Li 

伦理委员会联系地址:

广州市越秀区大德路111号 

Contact Address of the ethic committee:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China 

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:

辽宁中医药大学附属医院 

Primary sponsor:

The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

辽宁省沈阳市皇姑区北陵大街33号 

Primary sponsor's address:

33 Beiling Street, Huanggu District, Shenyang, Liaoning  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州中医药大学第二附属医院(广东省中医院)

具体地址:

越秀区大德路111号

Institution
hospital:

The Second Affiliated Hospital of Guangzhou University of Chinese medicine (Guangdong Provincial Hospital of Chinese Medicine)

Address:

111 Dade Road, Yuexiu District

经费或物资来源:

中华人民共和国科学技术部 

Source(s) of funding:

Ministry of Science and Techology of the People's Republic of China 

研究疾病:

紧张型头痛 

Target disease:

Tension-type headache 

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:

上市后药物 

Study phase:

研究目的:

评价血府逐瘀口服液治疗紧张型头痛气滞血瘀证患者的有效性和安全性,同时观察、收集非气滞血瘀证紧张型头痛患者在真实世界临床实践数据,比较、分析和评价血府逐瘀口服液对紧张型头痛患者证候变化的影响以及其与临床结局关联性。 

Objectives of Study:

To evaluate the efficacy and safety of Xuefu Zhuyu oral liquid in the treatment of tension-type headache with Qi-Stagnation and Blood-Stasis Pattern,and compare,analyze and evaluate the pattern change of tension-type headache and the association between pattern change and clinical outcomes  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

RCT 纳入标准: 1. TTH的出现至少大于1年,每月至少有2天的TTH(频率次数不限),至少曾有一次TTH的发作≥4h; 2. 视觉模拟评分(visual analogus scale, VAS)评分≥3cm; 3. TTH的首次发作在50岁以前; 4. 年龄18-65岁; 5. 中医辨证为气滞血瘀证; 6. 签署知情同意。 观察性研究纳入标准: 1.中医辨证为非气滞血瘀证,余纳入标准同RCT纳入标准。 

Inclusion criteria

RCT 1. TTH should be at least more than 1 year, at least 2 days per month (unlimited frequency), and at least one attack of TTH should be more than 4 hours; 2. Visual analog scale (VAS) score >= 3cm; 3. The first attack of TTH was before 50 years old; 4. Aged 18-65 years; 5. TCM syndrome differentiation is Qi stagnation and blood stasis; 6. Sign informed consent. Observational study TCM syndrome differentiation is non Qi stagnation and blood stasis 

排除标准:

RCT 1.合并偏头痛; 2.半年内的头颅CT平扫和经颅多普勒超声检查(TCD)结果证明为继发的头痛; 3.合并有心血管、肝、肾和造血系统等严重原发性疾病及精神病(精神分裂症,癫痫,酗酒,厌食等或有重大神经精神疾病史,具体包括中度的心律失常、慢性阻塞性肺疾病、急性或亚急性重症肝炎、慢性肾衰、糖尿病、肿瘤、精神分裂症等疾病; 4. 实验室检查提示谷丙转氨酶或谷草转氨酶增高>2倍正常值上限;肌酐增高>1.5倍正常值上限; 5. 患有其他严重疼痛疾病的,如癌症疼痛; 6. 焦虑自评量表(Self-Rating Anxiety Scale, SAS)评分大于59或抑郁自评量表(Self-rating depression scale,SDS)大于62的患者,或合并其他精神疾病的患者或严重认知障碍者; 7. 可能对试验药物过敏的; 8. 计划妊娠、已经怀孕和正在哺乳期的女性; 9. 正在参加其它药物临床试验者或1个月内参加过其它临床试验者。 观察性研究: 1. 合并偏头痛; 2. 半年内的头颅CT平扫和经颅多普勒超声检查(TCD)结果证明为继发的头痛; 3. 计划妊娠、已经怀孕和正在哺乳期的女性; 4. 正在参加其它药物临床试验者或1个月内参加过其它临床试验者。 

Exclusion criteria:

RCT 1. Migraine; 2. The results of CT scan and TCD in half a year proved to be secondary headache. 3. Combined with cardiovascular, liver, kidney and hematopoietic system and other serious primary diseases and mental disorders (schizophrenia, epilepsy, alcoholism, anorexia, etc.) or major neuropsychiatric history, including moderate arrhythmia, chronic obstructive pulmonary disease, acute or subacute severe hepatitis, chronic renal failure, diabetes, cancer, schizophrenia and other diseases. 4. Laboratory examination showed that the increase of ALT or AST was more than 2 times of the upper limit of normal value, and the increase of creatinine was more than 1.5 times of the upper limit of normal value. 5. Suffering from other severe pain diseases, such as cancer pain; 6. Patients with self rating Anxiety Scale (SAS) greater than 59 or self rating Depression Scale (SDS) greater than 62, or patients with other mental diseases or severe cognitive disorders; 7. May be allergic to the test drug; 8. Planned pregnancy, pregnant and lactating women; 9. Those who are participating in clinical trials of other drugs or have participated in other clinical trials within one month. Observational study 1. Migraine; 2. The results of CT scan and TCD in half a year proved to be secondary headache 3. Planned pregnancy, pregnant and lactating women; 4. Those who are participating in clinical trials of other drugs or have participated in other clinical trials within one month. 

研究实施时间:

Study execute time:

From2019-11-01To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2019-11-01To 2021-09-01 

干预措施:

Interventions:

组别:

试验组

样本量:

87

Group:

Treatment Group

Sample size:

干预措施:

血府逐瘀口服液

干预措施代码:

Intervention:

Xuefu Zhuyu Oral Liquid

Intervention code:

组别:

对照组

样本量:

87

Group:

Control Group

Sample size:

干预措施:

血府逐瘀口服液安慰剂

干预措施代码:

Intervention:

Placebo of Xuefu Zhuyu Oral Liquid

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

辽宁中医院大学附属医院 

单位级别:

三甲 

Institution
hospital:

The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广州中医药大学第二附属医院(广东省中医院) 

单位级别:

三甲 

Institution
hospital:

The Second Affiliated Hospital of Guangzhou University of Chinese medicine (Guangdong Provincial Hospital of Chinese Medicine)  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

辽宁中医药大学附属第二医院 

单位级别:

三甲 

Institution
hospital:

The Second Hospital Affiliated to Liaoning University Traditional Chinese Medicine  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

中国医科大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Hospital of China Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

沈阳市第十人民医院 

单位级别:

三甲 

Institution
hospital:

Shenyang 10th people's Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

内蒙古 

市(区县):

 

Country:

China 

Province:

Inner Mongolia 

City:

 

单位(医院):

内蒙古民族大学附属医院 

单位级别:

三甲 

Institution
hospital:

Affiliated Hospital of Inner Mongolia University for the Nationalities  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

治疗前后平均疼痛强度差值

指标类型:

主要指标 

Outcome:

Difference of average pain intensity before and after treatment

Type:

Primary indicator 

测量时间点:

测量方法:

采用视觉模拟评分(visual analogus scale, VAS)评定法测量

Measure time point of outcome:

Measure method:

指标中文名:

头痛曲线下面积

指标类型:

次要指标 

Outcome:

Area-under-the headache curve

Type:

Secondary indicator 

测量时间点:

测量方法:

计算每个观察期内每天的头痛持续时间(hours)×每天头痛强度的和再除以观察期来计算

Measure time point of outcome:

Measure method:

指标中文名:

头痛频率

指标类型:

次要指标 

Outcome:

Fruqency of headache

Type:

Secondary indicator 

测量时间点:

测量方法:

每个观察期头痛发作的次数 ;每个观察期头痛的天数 ;有效率(头痛频率减少50%被认为是有效)

Measure time point of outcome:

Measure method:

指标中文名:

头痛时间

指标类型:

次要指标 

Outcome:

Total time of headache

Type:

Secondary indicator 

测量时间点:

测量方法:

每个观察期内头痛的总时间

Measure time point of outcome:

Measure method:

指标中文名:

中医症状舌脉象采集表

指标类型:

次要指标 

Outcome:

A questionnaire of Symptoms including tongue and pulse of traditional Chinese medicine

Type:

Secondary indicator 

测量时间点:

测量方法:

使用中医症状舌脉象采集表,判断患者中医证候,包括气滞血瘀证以及其他证候

Measure time point of outcome:

Measure method:

指标中文名:

欧洲生存质量测定量表

指标类型:

次要指标 

Outcome:

EQ-5D-5L

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

止痛药物使用

指标类型:

次要指标 

Outcome:

the usage of painkillers

Type:

Secondary indicator 

测量时间点:

测量方法:

根据两组服用急救药物的剂量、频率和总量来评价血府逐瘀口服液是否能减少急救药物的使用

Measure time point of outcome:

Measure method:

指标中文名:

药物整体评价

指标类型:

次要指标 

Outcome:

Global evaluation of medication

Type:

Secondary indicator 

测量时间点:

测量方法:

采用简单的言语量表来评价药物的整体疗效,包括非常差、差、不好不坏、好、非常好 5个等级(1:非常差;2:差;3:不好不坏;4:好;5:非常好)。观察性研究中可不进行该指标评价。

Measure time point of outcome:

Measure method:

指标中文名:

卫生经济学指标

指标类型:

次要指标 

Outcome:

health economic indexes

Type:

Secondary indicator 

测量时间点:

测量方法:

挂号诊察费(如有),化验检查费,药费(除试验用药外),住院费(如有),交通费,平均月工资,家属陪同的费用折算(误工费,交通费,食宿费)

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

blood

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 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):

中国中医科学院临床基础研究所采用SAS软件产生随机序列,观察性研究不进行随机。

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

SAS software is used to generate random sequenceby institute of basic research in clinical medicine,China Academy of Chinese Medical Sciences,while, patients participate in the observational study will not be randomized.

盲法:

RCT 采用双盲设计,观察性研究不设盲

Blinding:

Double Blind is adopted in RCT, while there is no blinding in observational study.

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

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):

向主要研究者申请后可公开

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

Provided based on requirement

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:

电子采集和管理系统(Electronic Data Capture, EDC)

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

Electronic Data Capture, EDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2019-10-19
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