基于命门学说从"髓枯血瘀"病机探讨髓劳病(再生障碍性贫血)证候演变规律及临床应用

注册号:

Registration number:

ITMCTR2024000080

最近更新日期:

Date of Last Refreshed on:

2024-05-27

注册时间:

Date of Registration:

2024-05-27

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

基于命门学说从"髓枯血瘀"病机探讨髓劳病(再生障碍性贫血)证候演变规律及临床应用

Public title:

Based on the theory of life gate, the evolution law and clinical application of marrow disease ( aplastic anemia ) syndrome were discussed from the pathogenesis of ' marrow withered blood stasis '.

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于命门学说从"髓枯血瘀"病机探讨髓劳病(再生障碍性贫血)证候演变规律及临床应用

Scientific title:

Based on the theory of life gate, the evolution law and clinical application of marrow disease ( aplastic anemia ) syndrome were discussed from the pathogenesis of ' marrow withered blood stasis '.

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:

董南希

研究负责人:

叶宝东

Applicant:

Nanxi Dong

Study leader:

Baodong Ye

申请注册联系人电话:

Applicant telephone:

+86-0571-86620325

研究负责人电话:

Study leader's telephone:

+86-0571-86620325

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:

dnx15988828779@outlook.com

研究负责人电子邮件:

Study leader's E-mail:

13588453501@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:

浙江中医药大学滨文路548号

研究负责人通讯地址:

浙江省杭州市浙江省中医院邮电路54号

Applicant address:

Zhejiang Province Hangzhou Binwen Road No.548

Study leader's address:

Zhejiang Province Hangzhou Zhejiang Province of Traditional Chinese Medicine Hospital Posts and Telecommunications Road No.54

申请注册联系人邮政编码:

Applicant postcode:

310000

研究负责人邮政编码:

Study leader's postcode:

310000

申请人所在单位:

浙江中医药大学

Applicant's institution:

Zhejiang Chinese Medical University First Clinical Medical College

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:

2024-KL-284-01

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:

浙江中医药大学附属第一医院伦理委员会

Name of the ethic committee:

ethical committee of the First Affiliated Hospital of Zhejiang Chinese Medical University

伦理委员会批准日期:

Date of approved by ethic committee:

2024/4/30 0:00:00

伦理委员会联系人:

夏冰

Contact Name of the ethic committee:

Bing Xia

伦理委员会联系地址:

浙江省杭州市上城区邮电路23号,浙江长城资产大楼320伦理办公室

Contact Address of the ethic committee:

District23 Youdian Rd,Hangzhou(310006),,Zhejiang,China

伦理委员会联系人电话:

Contact phone of the ethic committee:

13600519473

伦理委员会联系人邮箱:

Contact email of the ethic committee:

18324440606@163.com

研究实施负责(组长)单位:

浙江中医药大学附属第一医院(浙江省中医院)

Primary sponsor:

The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine)

研究实施负责(组长)单位地址:

浙江省杭州市浙江省中医院邮电路54号

Primary sponsor's address:

( Youdian Rd ) Zhejiang Provincial Hospital of Traditional Chinese Medicine Lakeshore Shangcheng District54 Youdian Rd

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江省

市(区县):

杭州市

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江中医药大学附属第一医院(浙江省中医院)

具体地址:

浙江省杭州市浙江省中医院邮电路54号

Institution
hospital:

The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine)The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine)

Address:

( Youdian Rd ) Zhejiang Provincial Hospital of Traditional Chinese Medicine Lakeshore Shangcheng District54 Youdian Rd

经费或物资来源:

浙江省科技计划项目,“尖兵领雁+X”研发攻关计划

Source(s) of funding:

“Leading Geese” Research and Development Plan of Zhejiang Province

研究疾病:

再生障碍性贫血

研究疾病代码:

Target disease:

Aplastic Anemia

Target disease code:

研究类型:

Study type:

观察性研究

Observational study

研究设计:

Study design:

队列研究

Cohort study

研究所处阶段:

Study phase:

其它

Others

研究目的:

(1)构建髓劳病(再生障碍性贫血)科研数据平台,优化再障文献智能化数据库,构建再障生物信息数据库。 (2)通过前瞻性、多中心真实世界研究,明确基于命门学说从 “髓枯血瘀”病机体系指导下再障“二型六证”分型诊治策略的科学性及可行性。参加国内国际会议学术交流,推广该诊治策略至全国省级医疗单位不少于10家,全身涵盖省市县医疗单位不少于10家。 (3)总结发表项目研究成果,形成专家共识,制定诊疗指南。

Objectives of Study:

( 1 ) Construct a research data platform for medullary disease ( aplastic anemia ), optimize the intelligent database of aplastic anemia literature, and construct aplastic anemia biological information database. ( 2 ) Through prospective, multi-center real world research, the scientificity and feasibility of the diagnosis and treatment strategy of ' two types and six syndromes ' of aplastic anemia under the guidance of the pathogenesis system of ' marrow withered and blood stasis ' based on the theory of life gate were clarified. Participate in academic exchanges at domestic and international conferences, and promote the diagnosis and treatment strategy to no less than 10 provincial medical units nationwide, covering no less than 10 medical units in provinces, cities and counties. ( 3 ) Summarize and publish the research results of the project, form expert consensus, and formulate diagnosis and treatment guidelines.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

同时具备下列 6 项:①符合髓劳病(再障)诊断标准,参考再障诊断与治疗中国指南(2022年版);②患者年龄范围16~80岁;③首次诊断后,未使用过标准方案治疗,或当前治疗方案已维持超过3个月;④纳入疗效分析的患者,药物治疗至少维持12周;⑤能依从研究访视时间表,并理解和依从所有研究方案要求;⑥能够理解并自愿签署书面知情同意书。

Inclusion criteria

At the same time, it has the following 6 items : 1 in line with the diagnostic criteria of medullary labor disease ( aplastic anemia ), with reference to the Chinese guidelines for the diagnosis and treatment of aplastic anemia ( 2022 edition ) ; 2 patients aged from 16 to 80 years old ; 3 after the first diagnosis, no standard regimen was used, or the current treatment regimen had been maintained for more than 3 months ; patients included in the efficacy analysis were treated with drugs for at least 12 weeks ; 5 to comply with the study visit schedule, and understand and comply with all research program requirements ; 6 to understand and voluntarily sign a written informed consent.

排除标准:

①严重心脏病包括纽约心脏病协会(NYHA)III或Ⅳ级充血性心力衰竭无法控制的高血压或低血压,或严重的瓣膜或心内膜疾病,导致受试者存在血栓栓塞的风险;②临床活动的或未受控制的持续炎性/自身免疫性疾病(例如类风湿关节炎、克罗恩病、溃疡性结肠炎、乳糜泻、系统性红斑狼疮等)。

Exclusion criteria:

1 Severe heart disease included uncontrolled hypertension or hypotension, or severe valvular or endocardial disease in New York Heart Association ( NYHA ) grade III or IV congestive heart failure, resulting in the risk of thromboembolism in the subjects. 2 Clinically active or uncontrolled persistent inflammatory / autoimmune diseases ( such as rheumatoid arthritis, Crohn 's disease, ulcerative colitis, celiac disease, systemic lupus erythematosus, etc. ).

研究实施时间:

Study execute time:

From 2024-01-01

To      2026-12-31

征募观察对象时间:

Recruiting time:

From 2024-07-01

To      2026-06-30

干预措施:

Interventions:

组别:

西医治疗组

样本量:

74

Group:

control group

Sample size:

干预措施:

基础西药治疗方案

干预措施代码:

Intervention:

Basic treatment plan

Intervention code:

组别:

肾虚精伤,髓亏瘀阻证

样本量:

71

Group:

Kidney deficiency and essence injury, marrow deficiency, and blood stasis syndrome

Sample size:

干预措施:

温肾养血活络方

干预措施代码:

Intervention:

Wenshen Yangxue Huoluo Decoction

Intervention code:

组别:

脾肾气虚,髓枯络伤证

样本量:

71

Group:

Spleen–Kidney?Qi-deficiency, marrow, and collaterals deficiency syndrome

Sample size:

干预措施:

补肾健脾摄血方

干预措施代码:

Intervention:

Bushen Jianpi Huoxue Decoction

Intervention code:

组别:

肾虚精亏,髓枯血闭证

样本量:

71

Group:

Marrow and essence deficiency, the depletion of marrow, and blood occlusion syndrome

Sample size:

干预措施:

补肾填精活血方

干预措施代码:

Intervention:

Bushen Tianjing Huoxue Decoction

Intervention code:

组别:

气血虚弱,髓亏血瘀证

样本量:

71

Group:

Qi and blood weakness, marrow deficiency, and blood stasis syndrome

Sample size:

干预措施:

生脉养髓汤

干预措施代码:

Intervention:

Sheng Mai Yang Sui Decoction

Intervention code:

组别:

髓枯精虚,热入营血证

样本量:

71

Group:

Marrow and essence deficiency, and blood-heat syndrome

Sample size:

干预措施:

补肾填精凉血方

干预措施代码:

Intervention:

Bushen Tianjing Liangxue Decoction

Intervention code:

组别:

脾虚湿阻,髓亏痰凝证

样本量:

71

Group:

Spleen?deficiency?and?dampness, marrow deficiency and phlegm?coagulation syndrome

Sample size:

干预措施:

温脾燥湿化痰方

干预措施代码:

Intervention:

Wenpi Zaoshi Huatan Decoction

Intervention code:

样本总量 Total sample size : 500

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

浙江省

市(区县):

杭州市

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江中医药大学附属第一医院(浙江省中医院)

单位级别:

省级

Institution/hospital:

The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine)The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine)

Level of the institution:

Province

国家:

中国

省(直辖市):

浙江省

市(区县):

杭州市

Country:

China

Province:

Zhejiang

City:

Hanghzou

单位(医院):

浙江大学医学院附属第二医院

单位级别:

省级

Institution/hospital:

The Second Affiliated Hospital of Zhejiang University

Level of the institution:

Province

国家:

中国

省(直辖市):

浙江省

市(区县):

义乌市

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江大学医学院附属第四医院

单位级别:

省级

Institution/hospital:

The Fourth Affiliated Hospital of Zhejiang University

Level of the institution:

Province

国家:

中国

省(直辖市):

浙江省

市(区县):

杭州市

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

杭州市第一人民医院

单位级别:

市级

Institution/hospital:

Hangzhou First People 's Hospital

Level of the institution:

municipal

测量指标:

Outcomes:

指标中文名:

炎症代谢

指标类型:

次要指标

Outcome:

inflammation and metabolism

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

12周有效率

指标类型:

主要指标

Outcome:

Effective rate at 12 weeks

Type:

Primary indicator

测量时间点:

治疗前、治疗后4周、8周、12周

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

凝血功能

指标类型:

副作用指标

Outcome:

coagulation function

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

超声检查

指标类型:

副作用指标

Outcome:

ultrasonic examination

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脂质代谢

指标类型:

次要指标

Outcome:

lipid metabolism

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心电图

指标类型:

副作用指标

Outcome:

electrocardiogram

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

葡萄糖测定

指标类型:

副作用指标

Outcome:

determination of glucose

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生化指标

指标类型:

副作用指标

Outcome:

biochemical index

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

大便常规

指标类型:

副作用指标

Outcome:

stool routine

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺部CT

指标类型:

副作用指标

Outcome:

lung CT

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿常规

指标类型:

副作用指标

Outcome:

urinalysis

Type:

Adverse events

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:

骨髓液

组织:

Sample Name:

bone marrow

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:

尚未开始

Not yet recruiting

年龄范围:

最小 16
Min age years
最大 80
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):

本研究为采用非随机方法的真实世界研究。

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

This study is a real-world study using non-randomized methods.

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

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):

不共享

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

no sharing

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:

病例记录表

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

CRF

数据管理委员会:

Data Managemen Committee:

No

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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