ChiCTR2200062011 版本V1.2 版本创建时间2022/07/19 13:14:16 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：

 ChiCTR2200062011 

最近更新日期：

Date of Last Refreshed on：

 2022-07-19 13:13:24 

注册时间：

Date of Registration：

 2022-07-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

芪桂复元汤在中风后康复和防复发的效用及促进神经再生的机制研究

Public title：

Effect of QIGUI FUYUAN decoction on rehabilitation and recurrence prevention after stroke and its mechanism of promoting nerve regeneration

注册题目简写：

English Acronym：

研究课题的正式科学名称：

芪桂复元汤在中风后康复和防复发的效用及促进神经再生的机制研究

Scientific title：

Effect of Qi-Gui Fu-Yuan decoction on rehabilitation and recurrence prevention after stroke and its mechanism of promoting nerve regeneration

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：

ChiMCTR2200006366

申请注册联系人：

姚宇剑 

研究负责人：

翁国虎 

Applicant：

YuJianYao 

Study leader：

GuoHuWeng 

申请注册联系人电话：

Applicant telephone：

 18289773848

研究负责人电话：

Study leader's
telephone：

18689931113

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：

 626239131@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 18689931113@163.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：

海南省海口市美兰区和平北路47号

研究负责人通讯地址：

海南省海口市美兰区和平北路47号

Applicant address：

No. 47 of Peace Road, Haikou, Hainan, China.

Study leader's address：

No. 47 of Peace Road, Haikou, Hainan, 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：

海南省中医院

Applicant's institution：

Clinical Research Laboratory of Chinese medicine hospital of HaiNan province

研究负责人所在单位：

Affiliation of the Leader：

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：

 HNSZYY-2022-LL-011

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：

海南省中医院医学伦理委员会

Name of the ethic committee：

Committee on medical ethics of Hainan Provincial Hospital of traditional Chinese medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-04-11 00:00:00

伦理委员会联系人：

林翠

Contact Name of the ethic committee：

cui Lin

伦理委员会联系地址：

海南省海口市和平北路47号海南省中医院

Contact Address of the ethic committee：

47 Heping North Road, Meilan District, Haikou City, Hainan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 0898-66210281

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：

海南省中医院

Primary sponsor：

Department of science and technology of Hainan Province

研究实施负责（组长）单位地址：

海南省海口市美兰区和平北路47号

Primary sponsor's address：

No. 47 of Peace Road, Haikou, Hainan, China.

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

海南省

市(区县)：

Country：

CHINA

Province：

Hainan

City：

单位(医院)：

海南省中医院

具体地址：

海南省海口市美兰区和平北路47号

Institution
hospital：

Chinese medicine hospital of HaiNan province

Address：

47 Heping North Road, Meilan District, Haikou City, Hainan Province

经费或物资来源：

海南省科学技术厅

Source(s) of funding：

Department of science and technology of Hainan Province

研究疾病：

缺血性脑卒中  

Target disease：

Ischemic stroke

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：

队列研究 

Study design：

Cohort study 

研究目的：

脑血管病是我国第一大死亡疾病，每年死亡人数超过200万，死亡率是欧美国家的4-5倍，该数据在随之而来的老年化社会将进一步攀升，防治任务很重。在急性脑卒中构成中，大约有75%属于缺血性脑卒中。静脉溶栓和动脉介入治疗是治疗缺血性脑卒中的重要举措。尽管近年来脑血管病的诊断、治疗及二级预防取得了很大的进展，但中风患者出院后的康复和复发情况不容乐观。 中医药治疗中风有着悠久的历史，脑卒中发病急骤，变化迅速，与自然界里风性善行而数变相似，因此命名为中风。中医学认为中风病是在气血内虚的基础上，风、痰、瘀等多种因素共同作用于人体，导致脑脉痹阻。黄芪桂枝五物汤记载于《金匮要略》，由黄芪、芍药、桂枝、生姜、大枣组成，功效为调养营卫、祛风散邪、益气温经、和血通痹，是治疗脑脉痹阻所致中风后遗症的重要方剂。 关于黄芪桂枝五物汤治疗中风开展的临床与基础研究比较丰富。已有研究发现，黄芪桂枝五物汤对改善脑梗死后遗留肢体乏力、语言謇塞效果显著，可缩短病程、改善上肢运动功能和日常生活能力。此外，对脑梗死后遗症期患者应用黄芪桂枝五物汤联合针灸治疗效果良好，对促进神经功能恢复、改善血液流变情况、提高日常生活能力具有显著效果。 我们在该经典方剂的临床使用和前期研究的基础上，结合海南本地患者体质与用药习惯，在黄芪桂枝五物汤基础上加入五指毛桃、防风、天麻、杜仲、地龙、僵蚕、羌活、独活组成芪桂复元汤。经前期预实验观察发现，急性期使用芪桂复元汤够更快地促进急性卒中患者改善肌力、语言能力和肢体麻木的症状；复诊或前来康复的慢性期病人服用该方后也可使遗留的肢体运动和语言功能更快地得到改善，提高生活质量。此外，积极参与二级预防的中风病人服用芪桂复元汤后再次发生心脑血管病事件的比例降低。然而，芪桂复元汤尚未经过系统的临床观察研究，须进一步确证疗效。 脑梗死恢复期的肢体运动、麻木和语言功能均与神经再生并形成有功能的神经环路密不可分。深入研究芪桂复元汤对神经再生的作用，不仅可以进一步了解芪桂复元汤疗效的作用机制，并且可以为脑中风后改善脑部微环境、调控神经再生提供新的思路和方向。 “既病防变”和“病后防复发”是中医治未病的两大内容。本研究将从临床出发观察芪桂复元汤在中风后康复和防复发的效用，深入阐明该方在“既病防变”和“病后防复发”中发挥的重要作用，为更好地传承创新中医治未病理论、挖掘芪桂复元汤临床效用奠定科学基础，为院内制剂研制和未来新药开发积累有关的科学资料，最终让更多中风患者获益。  

Objectives of Study：

Cerebrovascular disease is the first death disease in China. The number of deaths per year is over 2 million. The mortality rate is 4-5 times that of the European and American countries. The data will further increase in the aging society, and the prevention and control task is very heavy. Of the acute stroke composition, approximately 75% fall into the category of ischemic stroke. Intravenous thrombolysis and arterial intervention are important initiatives in the treatment of ischemic stroke. Although great progress has been made in the diagnosis, treatment, and secondary prevention of cerebrovascular disease in recent years, the rehabilitation and recurrence after discharge of stroke patients cannot be optimistic. The treatment of stroke in traditional Chinese medicine (TCM) has a long history, stroke has an acute onset, changes rapidly, and is similar to nature's wind, and therefore named stroke. Traditional Chinese medicine (TCM) considers stroke disease on the basis of the deficiency of Qi and blood within the body, and many factors, such as wind, phlegm, and stasis, work together to cause blockage of cerebral collaterals. Huangqi Guizhi Wuwu decoction, which is recorded in the synopsis of the golden chamber, consists of Radix Astragali, Radix Paeoniae lactiflora, Radix cinnamomi, Rhizoma Zingiberaceae, and Rhizoma Jujubae, and its efficacy is for regulating Yin Wei, Qufeng San Yin, Yiqi Wenjing, and xuetongbi, and it is an important prescription for treating the sequelae of stroke due to cerebral collaterals. There are abundant clinical and basic studies on the development of Huangqi Guizhi Wuwu Decoction for the treatment of stroke. Previous studies have found that Huangqi Guizhi Wuwu decoction is effective in ameliorating limb weakness and language sludging after cerebral infarction, which can shorten the disease course and improve the motor function of the upper limbs and the ability of daily living. In addition, the combination of Huangqi Guizhi Wuwu Decoction and acupuncture in patients at the sequelae stage of cerebral infarction is highly effective in promoting the recovery of neurological function, improving the condition of blood rheology, and improving the ability of daily living. On the basis of the clinical use of this classic formula and a previous study, combined with the physical and medication habits of native patients in Hainan, wuzhiwuwu decoction was supplemented with a combination of wufinger peach, Fangfeng, Gastrodia elata Blume, Eucommia ulmoides, Dilong, stiff silkworm, Qiang, and single Huo into Qigui FUYUAN decoction. Our previous pre experimental observation found that Qigui FUYUAN decoction during the acute phase was able to promote faster improvement of symptoms of muscle strength, language ability and limb numbness in patients with acute stroke; Return visits or visits to the rehabilitation unit for patients in the chronic phase after taking the party can also lead to faster improvements in motor and language functions of the remaining limbs and improve the quality of life. In addition, stroke patients who were actively involved in secondary prevention had a lower rate of recurrent cardio cerebrovascular events after taking Qigui FUYUAN decoction. However, Qigui FUYUAN decoction has not undergone a systematic clinical observation study, and the efficacy should be further confirmed. Limb movement, numbness, and language function during recovery from cerebral infarction are all inextricably linked to nerve regeneration and the formation of functional neural circuits. In depth study of the effects of Qigui FUYUAN decoction on neuroregeneration will not only provide further insight into the mechanism underlying the efficacy of Qigui FUYUAN decoction, but also may provide new ideas and directions for improving the brain microenvironment and regulating neuroregeneration after stroke. "" both diseases and changes "" and "" prevention and recurrence after illness "" are the two main contents of TCM to treat no disease. This study will observe the utility of Qigui FUYUAN decoction in post-stroke rehabilitation and recurrence prevention from the clinical point of view, deeply clarify the important role this formula plays in "" both disease prevention and recurrence "" and provide a scientific foundation for better transmission of innovative theories of traditional Chinese medicine for treating no disease and mining the clinical utility of Qigui FUYUAN decoction, Accumulating relevant scientific data for in-hospital formulation development and future new drug development will eventually benefit more stroke patients.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

纳入标准：①符合上述西医诊断标准及中医辨证分型；②年龄在18岁~80岁者；③患者入组前2周均未服用任何中药；④肝肾功能正常者；⑤近期未参加其他临床药物试验者，或参加已停药半个月以上；⑥患者自愿受试且签署知情同意书。

Inclusion criteria

Inclusion criteria: ① meet the above diagnostic criteria of Western medicine and TCM syndrome differentiation; ② Those aged from 18 to 80; ③ The patients did not take any traditional Chinese medicine 2 weeks before enrollment; ④ Normal liver and kidney function; ⑤ Those who have not participated in other clinical drug trials recently, or have stopped taking drugs for more than half a month; ⑥ Patients volunteered for the trial and signed informed consent.

排除标准：

①年龄＜18岁或＞80岁者；②合并严重的肝、肺、心脏、肿瘤等疾病者；③任何形式的脑出血患者；④单纯的腔隙性脑梗死或后循环引起的脑梗死；⑤未按规定要求服药，无法判断治疗疗效，或资料不全等影响疗效判断者；⑥妊娠期和哺乳期妇女；⑦对所用药物过敏者及有精神意识障碍者。

Exclusion criteria：

① Age < 18 years old or > 80 years old; ② Patients with severe liver, lung, heart, tumor and other diseases; ③ Patients with any form of intracerebral hemorrhage; ④ Simple lacunar infarction or cerebral infarction caused by posterior circulation; ⑤ Failing to take medicine as required, unable to judge the therapeutic effect, or incomplete data affect the judgment of curative effect; ⑥ Pregnant and lactating women; ⑦ Those who are allergic to the drugs and have mental disorders.

研究实施时间：

Study execute time：

从 From 2022-08-01 00:00:00至 To 2023-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-08-01 00:00:00 至 To 2023-08-01 00:00:00

干预措施：

Interventions：

组别：

中药治疗组

样本量：

 80

Group：

TCM treatment group

Sample size：

干预措施：

接受常规治疗+服用芪桂复元汤

干预措施代码：

Intervention：

Received usual care and Taking Qigui FUYUAN decoction

Intervention code：

组别：

对照组

样本量：

 80

Group：

control group

Sample size：

干预措施：

接受常规治疗

干预措施代码：

Intervention：

Received usual care

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 海南省 

市(区县)：

  

Country：

China

Province：

Hainan

City：

单位(医院)：

 海南省中医院 

单位级别：

 三甲医院 

Institution
hospital：

Chinese medicine hospital of HaiNan province

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

美国国立卫生研究院卒中量表

指标类型：

主要指标

Outcome：

National Institute of Health stroke scale(NIHSS)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

改良Rankin评分量表

指标类型：

主要指标

Outcome：

ModifiedRankinScale(mRS)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肝、肾功能

指标类型：

主要指标

Outcome：

Alaninetransaminase/aspartate amino transferase(ALT/AST)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

日常生活活动能力

指标类型：

主要指标

Outcome：

Barthel

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

中风复发率

指标类型：

主要指标

Outcome：

Recurrence rate of stroke

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血糖-随机血糖

指标类型：

次要指标

Outcome：

GLU

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血脂-低密度脂蛋白

指标类型：

次要指标

Outcome：

Lipid-low density lipoprotein(OX-LDL)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血压

指标类型：

次要指标

Outcome：

blood pressure

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肩手综合征发生率

指标类型：

次要指标

Outcome：

Incidence of Shoulder-hand Syndrome

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：

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：

标本中文名：

尿液

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：

标本中文名：

粪便

组织：

Sample Name：

faeces

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 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）：

由独立于治疗外的固定的一名临床研究实验室人员用随机数法将符合纳入标准的病人分组，反馈分组结果给医生。

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

Patients who met the inclusion criteria were grouped by random numbers by a clinical research laboratory staff independent of the fixation outside the treatment, and the grouped results were fed back to the physicians.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Blinding：

是否共享原始数据：

IPD sharing

否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）：

邮箱发送

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

e-mail

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：

Case Record Form

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

Case Record Form

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2022-07-19 13:13:05