中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2200066467
最近更新日期： Date of Last Refreshed on：	2023-05-06 16:10:41
注册时间： Date of Registration：	2022-12-06 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	“治痿独取阳明”论治下的火龙罐治疗缺血性中风痉挛性偏瘫疗效观察
Public title：	Observation on the curative effect of Huolongcan in the treatment of ischemic apoplexy spastic hemiplegia under the theory of
注册题目简写：
English Acronym：
研究课题的正式科学名称：	“治痿独取阳明”论治下的火龙罐治疗缺血性中风痉挛性偏瘫疗效观察
Scientific title：	Observation on the curative effect of Huolongcan in the treatment of ischemic apoplexy spastic hemiplegia under the theory of
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：	赵修芬	研究负责人：	赵修芬
Applicant：	Xiufen Zhao	Study leader：	Xiufen Zhao
申请注册联系人电话： Applicant telephone：	+86 13705957537	研究负责人电话： Study leader's telephone：	+86 13705957537
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：	fjsykjk@126.com
申请注册联系人电子邮件： Applicant E-mail：	3281560388@qq.com	研究负责人电子邮件： Study leader's E-mail：	3281560388@qq.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：	福建中医药大学附属第三人民医院	研究负责人通讯地址：	福建中医药大学附属第三人民医院
Applicant address：	The Third People's Hospital Affiliated with Fujian University of Traditional Chinese Medicine	Study leader's address：	The Third People's Hospital Affiliated with Fujian University of Traditional Chinese Medicine
申请注册联系人邮政编码： Applicant postcode：	350108	研究负责人邮政编码： Study leader's postcode：	350108
申请人所在单位：	福建中医药大学附属第三人民医院
Applicant's institution：	The Third People's Hospital Affiliated with Fujian University of Traditional Chinese Medicine
研究负责人所在单位：	福建中医药大学附属第三人民医院
Affiliation of the Leader：	The Third People's Hospital Affiliated with Fujian University of Traditional 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：	2020KS-50-1	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：	福建中医药大学附属第三人民医院伦理委员会
Name of the ethic committee：	Ethics Committee of the Third People's Hospital Affiliated to Fujian University of Chinese Medicine
伦理委员会批准日期： Date of approved by ethic committee：	2020-07-01 00:00:00
伦理委员会联系人：	蔡晶
Contact Name of the ethic committee：	Jing Cai
伦理委员会联系地址：	福建省福州市闽侯县上街镇国宾大道363号
Contact Address of the ethic committee：	363 Guobin Avenue, Shangshang Town, Minhou County, Fuzhou , Fujian
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：

福建中医药大学附属第三人民医院

Primary sponsor：

The Third People's Hospital Affiliated with Fujian University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

福建省福州市闽侯县上街镇国宾大道363号

Primary sponsor's address：

363 Guobin Avenue, Shangshang Town, Minhou County, Fuzhou, Fujian

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	福建	市(区县)：
Country：	China	Province：	Fujian	City：
单位(医院)：	福建中医药大学附属第三人民医院	具体地址：	福建省福州市闽侯县上街镇国宾大道363号
Institution hospital：	The Third People's Hospital Affiliated with Fujian University of Traditional Chinese Medicine	Address：	363 Guobin Avenue, Shangshang Town, Minhou County, Fuzhou, Fujian

经费或物资来源：

福建中医药大学

Source(s) of funding：

Fujian University of Chinese Medicine

研究疾病：

缺血性中风

Target disease：

ischemic apoplexy

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：

其它

Study phase：

N/A

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

观察“治痿独取阳明”论治下的火龙罐治疗对缺血性中风痉挛性偏瘫治疗前后的变化，进一步判断其临床疗效。

Objectives of Study：

To observe the changes before and after treatment of ischemic stroke spasmodic hemiplegia by Huolongcan therapy under the theory of "treating impotence and taking Yangming alone", and to further judge its clinical efficacy.

药物成份或治疗方案详述：

1 对照组 ①基础药物治疗：参照《中国脑血管病防治指南》给予改善脑代谢、脑循环，防治脑水肿，营养脑神经，调节血脂，维持血糖、血压稳定，防治并发症等治疗。②常规护理：做好病情观察，生活起居护理，饮食调理，情志护理等，提高患者自我管理意识。③康复训练：根据患者实际情况开展运动功能、言语功能训练等。 2 试验组试验组给予基础药物治疗、常规护理和康复训练同对照组，另给予“治痿独取阳明”论治下的火龙罐治疗。

Description for medicine or protocol of treatment in detail：

1 Control group Methods for treating stroke in the control group involved: 1) Basic drug therapy: Improving brain metabolism and circulation, preventing and treating cerebral edema, nourishing brain nerves, regulating blood lipid levels, stabilizing blood glucose levels and blood pressure, and preventing and treating complications were administered as per the Guidelines for the Prevention and Treatment of Cerebrovascular Diseases in China. 2) Routine nursing: Illness monitoring, daily living nursing, diet conditioning, and emotional nursing care were provided, and patients were guided to improve their self-management awareness. 3) Rehabilitation training: The training on motor and speech functions was conducted according to the actual conditions of patients. 2 Experimental group In addition to the basic drug therapy, routine nursing and rehabilitation training administered to the control group, Huolong cupping therapy based on the "treating flaccidity through yang brightness meridian" theory was administered to the experimental group.

纳入标准：

Inclusion criteria

排除标准：

①伴有严重心、肺、肝、肾功能衰竭，造血系统、内分泌系统等严重原发性疾病，或合并糖尿病酮症酸中毒者；②认知功能障碍（如痴呆）或心理疾病、精神病患者；③继发性癫痫、脑外伤、脑肿瘤、脑寄生虫病；采用过溶栓治疗的患者；大面积脑梗死或有脑疝倾向；或经检查证实由风湿性心脏病、冠心病合并房颤引起脑栓塞者；④妊娠或哺乳期妇女；⑤运动功能障碍（如类风湿性关节炎、关节畸形、骨折、外伤等）；⑥皮肤病或皮肤破损；⑦中风次数≧2 次；⑧两周内服用过影响肌张力的药物者。

Exclusion criteria：

1. Patients with severe heart, lung, liver, kidney failure, hematopoietic system, endocrine system and other serious primary diseases, or diabetic ketoacidosis; 2. Cognitive dysfunction (such as dementia) or mental illness, psychiatric patients; 3. Secondary epilepsy, brain trauma, brain tumor, cerebral parasitic disease; Patients treated with hyperthrombolytic therapy; Large area cerebral infarction or cerebral hernia tendency; Or cerebral embolism caused by rheumatic heart disease, coronary heart disease combined with atrial fibrillation; 4. Pregnant or lactating women; 5. Motor dysfunction (such as rheumatoid arthritis, joint deformity, fracture, trauma, etc.); 6. Skin disease or skin damage; 7. stroke frequency >=2 times; 8. Within two weeks of taking drugs that affect muscle tone.

研究实施时间：

Study execute time：

从 From 2020-08-01 00:00:00至 To 2022-02-28 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2020-08-01 00:00:00 至 To 2022-02-28 00:00:00

干预措施：

Interventions：

组别：	对照组	样本量：	50
Group：	The control group	Sample size：	50
干预措施：	基础药物治疗、常规护理、康复训练	干预措施代码：
Intervention：	Basic drug treatment, routine nursing, rehabilitation training	Intervention code：

组别：	试验组	样本量：	50
Group：	Experimental group	Sample size：	50
干预措施：	给予基础药物治疗、常规护理和康复训练同对照组，另给予“治痿独取阳明”论治下的火龙罐治疗。	干预措施代码：
Intervention：	The patients were given basic drug treatment, routine nursing and rehabilitation training as the control group. The patients were also given fire dragon pot treatment under the theory of "treating impotence by taking Yangming alone".	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	福建	市(区县)：
Country：	China	Province：	Fujian	City：
单位(医院)：	福建中医药大学附属第三人民医院	单位级别：	三级甲等
Institution hospital：	The Third People's Hospital of Fujian University of Traditional Chinese Medicine	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	改良 Ashworth 痉挛评定量表	指标类型：	主要指标
Outcome：	Modified Ashworth spasticity Rating Scale	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	四肢简化Fugl-Meyer运动功能评分	指标类型：	主要指标
Outcome：	Simplified Fugl-Meyer Motor function score of limbs	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 Barthel 指数评定量表	指标类型：	主要指标
Outcome：	Modified Barthel Index Rating Scale	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：

标本中文名：	无	组织：
Sample Name：	Nil	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：

最小 Min age	40	岁 years
最大 Max age	75	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）：

将研究对象编号，从随机数字表第5行第4列开始，将查出的随机数字依次标在编号的下面，遇奇数分入试验组，偶数分入对照组，每组 50 例。

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

The subjects were numbered, starting from the fifth row and the fourth column of the random number table. In case of odd numbers, they were divided into the experimental group and even numbers into the control group, with 50 cases in each group.

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：	None
Blinding：	None
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	临床试验公共管理平台 http://www.medresman.org.cn
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Clinical Trial Management Public Platform http://www.medresman.org.cn
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：	采用SPSS 22.0进行数据分析，符合正态性和方差齐性的计量资料描述采用均数加减标准差，两组间比较采用两独立样本t检验；计数资料采用构成比或率表示，组间比较采用卡方检验。采用重复测量方差分析对两组间和不同干预时间的指标进行单独效应和交互作用的分析，两两比较的方法为Bonferroni法,以P＜0.05表示差异有统计学意义。符合球形检验的使用一元方差分析结果，不符合的使用多元方差分析结果。作图软件为 Graphpad prism。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	SPSS 22.0 was used for data analysis. Measurement data consistent with normality and homogeneity of variance were described by mean plus or minus standard deviation, and comparison between two groups was performed by two independent sample t-test. Enumeration data were expressed as constituent ratio or rate, and chi-square test was used for comparison between groups. Repeated measures ANOVA was used to analyze the individual effects and interactions between the two groups and different intervention times. Bonferroni's method was used for pairwise comparison. P < 0.05 was considered statistically significant. The results of univariate analysis of variance were used for those who met the spherical test, and the results of multivariate analysis of variance were used for those who did not. The mapping software was Graphpad Prism.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2022-12-06 15:35:56