中医吐纳功法治疗慢性下肢静脉功能不全的随机、对照、多中心临床研究

注册号:

Registration number:

ITMCTR2024000018

最近更新日期:

Date of Last Refreshed on:

2024-02-17

注册时间:

Date of Registration:

2024-02-17

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

中医吐纳功法治疗慢性下肢静脉功能不全的随机、对照、多中心临床研究

Public title:

A randomized, controlled, multicenter clinical study of TCM Tuna Gong in the treatment of chronic lower extremity venous insufficiency

注册题目简写:

English Acronym:

研究课题的正式科学名称:

中医吐纳功法治疗慢性下肢静脉功能不全的随机、对照、多中心临床研究

Scientific title:

A randomized, controlled, multicenter clinical study of TCM Tuna Gong in the treatment of chronic lower extremity venous insufficiency

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:

史宏硕

研究负责人:

柳国斌

Applicant:

Hongshuo Shi

Study leader:

Guobin Liu

申请注册联系人电话:

Applicant telephone:

17510413109

研究负责人电话:

Study leader's telephone:

15800885533

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:

jf17510413109@163.com

研究负责人电子邮件:

Study leader's E-mail:

15800885533@163.com

申请单位网址(自愿提供):

Study leader's 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:

上海市浦东新区张衡路528号上海中医药大学附属曙光医院(东院)

研究负责人通讯地址:

上海市浦东新区张衡路528号上海中医药大学附属曙光医院(东院)

Applicant address:

Affiliated Shuguang Hospital (East Campus) of Shanghai University of Traditional Chinese Medicine, 528 Zhangheng Road, Pudong New Area, Shanghai.

Study leader's address:

Affiliated Shuguang Hospital (East Campus) of Shanghai University of Traditional Chinese Medicine, 528 Zhangheng Road, Pudong New Area, Shanghai.

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:

上海中医药大学附属曙光医院

Applicant's institution:

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2023-1322-89-01

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

上海中医药大学附属曙光医院伦理委员会

Name of the ethic committee:

IRB of Shuguang Hospital affiliated with Shanghai University of TCM

伦理委员会批准日期:

Date of approved by ethic committee:

2023/4/26 0:00:00

伦理委员会联系人:

耿希

Contact Name of the ethic committee:

Xi Geng

伦理委员会联系地址:

上海市浦东新区张衡路528号上海中医药大学附属曙光医院(东院)

Contact Address of the ethic committee:

Affiliated Shuguang Hospital (East Campus) of Shanghai University of Traditional Chinese Medicine, 528 Zhangheng Road, Pudong New Area, Shanghai.

伦理委员会联系人电话:

Contact phone of the ethic committee:

021-20256070

伦理委员会联系人邮箱:

Contact email of the ethic committee:

sgyyllwyh@126.com

研究实施负责(组长)单位:

上海中医药大学附属曙光医院

Primary sponsor:

Shuguang Hospital, Shanghai University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

上海中医药大学附属曙光医院

Primary sponsor's address:

Shuguang Hospital, Shanghai University of Traditional Chinese Medicine

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海市

市(区县):

浦东新区

Country:

China

Province:

shanghai

City:

Pudong New Area

单位(医院):

上海中医药大学附属曙光医院

具体地址:

上海市浦东新区张衡路528号上海中医药大学附属曙光医院(东院)

Institution
hospital:

Shuguang Hospital, Shanghai University of Traditional Chinese Medicine

Address:

Affiliated Shuguang Hospital (East Campus) of Shanghai University of Traditional Chinese Medicine, 528 Zhangheng Road, Pudong New Area, Shanghai.

经费或物资来源:

上海市卫生健康委员会

Source(s) of funding:

Shanghai Municipal Health Commission

研究疾病:

慢性下肢静脉功能不全

研究疾病代码:

Target disease:

chronic venous insufficiency

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

治疗新技术临床试验

New Treatment Measure Clinical Study

研究目的:

为客观评价中医吐纳功法治疗下肢慢性静脉功能不全(C2~C5 级)的有效性及安全性,本研究拟设计随机、对照、多中心临床研究。

Objectives of Study:

To objectively evaluate the effectiveness and safety of traditional Chinese medicine Tuina technique in treating chronic venous insufficiency of the lower limbs (C2 to C5 levels), this study intends to design a randomized, controlled, multicenter clinical study.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

(1)受试者自愿参与研究并签署知情同意书; (2)年龄在 18 岁(含)至 65 岁之间(不含),性别不限; (3)符合 CVI 的诊断标准者; (4)临床分级为 C2~C5 级; (5)符合中医辨证为气虚血瘀证者。

Inclusion criteria

(1) Subjects voluntarily participate in the study and sign an informed consent form; (2) Age range from 18 years (inclusive) to 65 years (exclusive), regardless of gender; (3) Those who meet the diagnostic criteria for CVI; (4) Clinical grading is C2 to C5 levels; (5) Those who meet the criteria of traditional Chinese medicine differentiation as Qi deficiency and blood stasis syndrome.

排除标准:

(1)伴有急性深静脉血栓形成者; (2)妊娠期或哺乳期妇女; (3)伴有严重的心、肝、肾功能不全者; (4)伴有严重的感染性疾病、恶性肿瘤、自身免疫性疾病或代谢性疾病; (5)伴有严重呼吸系统疾病者; (6)营养不良者;

Exclusion criteria:

(1) Patients with acute Deep vein thrombosis; (2) Pregnant or lactating women; (3) Patients with severe heart, liver, and kidney dysfunction; (4) Accompanied with serious infectious diseases, malignant tumors, autoimmune diseases or metabolic diseases; (5) Those with serious Respiratory disease; (6) Malnourished individuals;

研究实施时间:

Study execute time:

From 2022-12-31

To      2024-02-20

征募观察对象时间:

Recruiting time:

From 2023-04-27

To      2024-02-20

干预措施:

Interventions:

组别:

对照组

样本量:

109

Group:

control group

Sample size:

干预措施:

医用弹力袜,根据患者腿围(肿胀最严重部位)选择 2 到 3 级长筒露趾医用弹力袜(除睡觉及洗澡时间外,患者需在白天持续穿戴),连续治疗 12 周。

干预措施代码:

Intervention:

Medical elastic socks, choose 2-3 levels of long tube open toe medical elastic socks based on the patient's leg circumference (the most severely swollen area) (patients need to wear them continuously during the day except for sleeping and bathing time), and continue treatment for 12 weeks

Intervention code:

组别:

试验组

样本量:

109

Group:

Test group

Sample size:

干预措施:

中医吐纳功法(每日做 2 次,早上起床时做 1 次,晚上临睡时做 1 次,每次时间保持在 15min 左右,每周 5 天,连续治疗 12 周,总共 120 次功法治疗)

干预措施代码:

Intervention:

The traditional Chinese medicine technique of breathing is performed twice a day, once in the morning when getting up, and once when going to bed at night. The duration of each session is maintained at around 15 minutes, 5 days a week, and continuous treatment is given for 12 weeks. A total of 120 sessions of the technique are given.

Intervention code:

样本总量 Total sample size : 218

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

上海市

市(区县):

虹口区

Country:

China

Province:

Shanghai City

City:

单位(医院):

上海中医药大学附属岳阳中西医结合医院

单位级别:

三级甲等

Institution/hospital:

Shanghai Traditional Chinese Medicine Integrated Hospital, Shanghai University of Traditional Chinese Medicine

Level of the institution:

Level III Class A

国家:

中国

省(直辖市):

上海市

市(区县):

浦东新区

Country:

China

Province:

Shanghai City

City:

单位(医院):

上海中医药大学附属曙光医院

单位级别:

三级甲等

Institution/hospital:

Shuguang Hospital, Shanghai University of Traditional Chinese Medicine

Level of the institution:

Level III Class A

国家:

中国

省(直辖市):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学医学院附属第九人民医院

单位级别:

三级甲等

Institution/hospital:

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Level of the institution:

Level III Class A

测量指标:

Outcomes:

指标中文名:

静脉临床严重程度评分

指标类型:

主要指标

Outcome:

VCSS

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛评分

指标类型:

次要指标

Outcome:

VAS score

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

溃疡发生率

指标类型:

次要指标

Outcome:

Ulcer incidence rate

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腿围测量

指标类型:

次要指标

Outcome:

Leg circumference measurement

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

慢性静脉疾病生活质量评分

指标类型:

次要指标

Outcome:

CIVIQ-20

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

静脉血流动力学评估

指标类型:

次要指标

Outcome:

Hemodynamic assessment of venous blood flow.

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

踝关节运动范围评估

指标类型:

次要指标

Outcome:

Ankle joint range of motion assessment.

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:

征募研究对象情况:

正在进行

Recruiting

年龄范围:

最小 18
Min age years
最大 65
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

本试验采用以中心为分层因素的区组随机设计,采用交互式网络应答系统(Interactive Web Response System, IWRS),将受试者按 1:1 的比例随机分配到试验组和对照组。

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

This experiment adopts a block randomized design with a center as a stratified factor, and uses the Interactive Web Response System (IWRS) to randomly assign participants to the experimental group and control group in a 1:1 ratio.

盲法:

Blinding:

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):

原始数据公开日期2027年1月1日,公开网站为中国临床试验注册平台的http://www.medresman.org.cn

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

The original data was released on January 1, 2027 and the public website is the China Clinical Trial Registration Platform located at 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:

 电子病历报告表(CRF):数据管理员根据试验方案设计构建,并根据逻辑核查计划(DVP)设置逻辑核查规则,通过测试并获申办方批准后发布使用。  数据录入:CRF 数据来源于原始记录,由数据录入人员根据 CRF 填写说明,将受试者访视数据及时录入 EDC。  源数据现场核查(SDV):监查员进行 CRF 数据与源数据的一致性核对,有问题可发疑问。  数据疑问和解答:疑问来源于 EDC 逻辑核查的系统疑问,监查员、数据管理员等人工疑问,研究者需及时解答疑问。数据管理员和监查员进行疑问批复,必要时可再次发出疑问,直至数据“清洁”。  研究者签名:数据录入完成并经 SDV 后,研究者进行电子签名审核确认。签名后如有数据修订,需重新签名。  数据库锁定:由主要研究者、申办者、统计分析人员和数据管理人员共同签署数据库锁定记录后,数据管理员进行数据库锁定。  数据库提交:数据管理员向统计人员提交数据库。  CRF 存档:每个受试者的 CRF 生成 PDF 电子文档保存。  数据管理报告:由数据管理员撰写。  EDC 关闭:统计分析完成后,数据管理员关闭数据库。

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

Electronic Medical Record Report Form (CRF): The data administrator designs and builds it based on the experimental plan and verifies it logically The plan (DVP) sets logical verification rules, which are tested and approved by the sponsor before being released for use. Data entry: The CRF data is sourced from the original records, and the data entry personnel will fill in the CRF instructions and Timely input of subject visit data into EDC. On site verification of source data (SDV): The inspector checks the consistency between CRF data and source data, and if there are any questions Questions can be asked. Data Questions and Answers: The questions originate from the system questions of EDC logic verification, which are monitored by inspectors and data administrators Researchers need to promptly answer artificial questions. Data administrators and inspectors provide approval for any questions, if necessary You can raise questions again until the data is' clean '. Researcher's signature: After the data entry is completed and passed through SDV, the researcher conducts an electronic signature review and confirmation. autograph If there are any data revisions in the future, a new signature is required. Database locking: jointly signed by main researchers, applicants, statistical analysts, and data management personnel After locking records in the database, the data administrator locks the database. Database submission: The data administrator submits the database to the statistician. CRF archiving: The CRF of each subject is generated and saved as a PDF electronic document. Data management report: written by the data administrator. EDC shutdown: After the statistical analysis is completed, the data administrator closes the database.

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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