Study on the Biomarker Screening of Idiopathic Pulmonary Fibrosis Based on Metabonomics and the Effect of TCM Treatment Based on Syndrome Differentiation

注册号:

Registration number:

ITMCTR2000003588

最近更新日期:

Date of Last Refreshed on:

2020-08-17

注册时间:

Date of Registration:

2020-08-17

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

基于代谢组学的特发性肺纤维化生物标志物筛选及中医辨证治疗的影响

Public title:

Study on the Biomarker Screening of Idiopathic Pulmonary Fibrosis Based on Metabonomics and the Effect of TCM Treatment Based on Syndrome Differentiation

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于代谢组学的特发性肺纤维化生物标志物筛选及中医辨证治疗的影响

Scientific title:

Study on the Biomarker Screening of Idiopathic Pulmonary Fibrosis Based on Metabonomics and the Effect of TCM Treatment Based on Syndrome Differentiation

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:

ChiCTR2000035807 ; ChiMCTR2000003588

申请注册联系人:

余学庆

研究负责人:

余学庆

Applicant:

Xueqing Yu

Study leader:

Xueqing Yu

申请注册联系人电话:

Applicant telephone:

+86 0371-66248624

研究负责人电话:

Study leader's telephone:

+86 0371-66248624

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:

yxqshi@163.com

研究负责人电子邮件:

Study leader's E-mail:

yxqshi@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:

中国河南省郑州市人民路19号

研究负责人通讯地址:

中国河南省郑州市人民路19号

Applicant address:

19 Renmin Road, Zhengzhou, Henan, China

Study leader's address:

19 Renmin Road, Zhengzhou, Henan, China

申请注册联系人邮政编码:

Applicant postcode:

450000

研究负责人邮政编码:

Study leader's postcode:

450000

申请人所在单位:

河南中医药大学第一附属医院

Applicant's institution:

The First Affiliated Hospital of Henan 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:

2019HL-097-01

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

河南中医药大学第一附属医院伦理委员会

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital of Henan University of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2019/9/10 0:00:00

伦理委员会联系人:

王春芳

Contact Name of the ethic committee:

Chunfang Wang

伦理委员会联系地址:

中国河南省郑州市人民路19号

Contact Address of the ethic committee:

19 Renmin Road, Zhengzhou, Henan, 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:

河南中医药大学第一附属医院

Primary sponsor:

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

中国河南省郑州市人民路19号

Primary sponsor's address:

19 Renmin Road, Zhengzhou, Henan, 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):

河南

市(区县):

郑州

Country:

China

Province:

Henan

City:

Zhenzhou

单位(医院):

河南中医药大学第一附属医院

具体地址:

金水区人民路19号

Institution
hospital:

The First Affiliated Hospital of Henan University of traditional Chinese Medicine

Address:

19 Renmin Road, Jinshui District

经费或物资来源:

专项经费

Source(s) of funding:

Special funds

研究疾病:

特发性肺纤维化

研究疾病代码:

Target disease:

idiopathic pulmonary fibrosis

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:

探索性研究/预试验

Pilot clinical trial

研究目的:

(1)基于代谢组学筛选IPF病证结合特异性生物标志物; (2)初步探索IPF中医辨证治疗疗效与代谢生物标志物的关系; (3)从代谢组学探讨中医药作用机制及疗效和预后评估的生物学指标。

Objectives of Study:

1.To screen special biomarkers on conbination of disease and syndrome of IPF based on serum metabolism. 2.To explore the relationship between the therapeutic effect of TCM treatment based on syndrome differentiation for IPF and metabolic biomarkers preliminarily. 3. To explore the biomarkers of curative effect and prognosis of TCM based on serum metabonomics.

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)符合IPF稳定期诊断的患者; (2)年龄40~80岁; (3)符合中医辨证诊断标准; (4)入选前1个月内未参加其他药物临床研究; (5)自愿接受治疗,并签署知情同意书。

Inclusion criteria

(1) Patients with stable IPF; (2) Aged 40-80 years; (3) In accord with the diagnostic criteria of TCM syndrome differentiation; (4) Not participate in any other interventional clinical trial within one month before selection; (5) Accept treatment voluntarily and sign the informed consent.

排除标准:

(1)妊娠或哺乳期妇女及近期有妊娠计划的患者; (2)神志不清、痴呆、各种精神疾病患者; (3)合并严重心功能不全、肝肾疾病、支气管哮喘、慢阻肺、神经系统疾病、肿瘤、胸廓畸形患者; (4)合并严重的关节、周围神经及周围血管病变影响肢体活动及长期卧床患者; (5)已知对治疗药物过敏者。

Exclusion criteria:

1. Pregnant, breastfeeding women or patients with a recent pregnancy plan; 2. Delirious, dementia, or with any mental disorder; 3. Complicated with severe cardiac insufficiency, liver and kidney diseases, bronchial asthma, chronic obstructive pulmonary disease, tumor or thoracic deformity; 4. With a condition of limb dysfunction or bedridden; 5. Known to be allergic to any component of the therapeutic drugs.

研究实施时间:

Study execute time:

From 2019-08-01

To      2020-12-31

征募观察对象时间:

Recruiting time:

From 2020-04-24

To      2020-12-31

干预措施:

Interventions:

组别:

对照组

样本量:

30

Group:

control group

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

TCM placebo

Intervention code:

组别:

试验组

样本量:

60

Group:

experimental group

Sample size:

干预措施:

中医辨证治疗

干预措施代码:

Intervention:

TCM treatment based on syndrome differentiation

Intervention code:

样本总量 Total sample size : 90

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

河南

市(区县):

Country:

China

Province:

He'nan

City:

单位(医院):

河南中医药大学第一附属医院

单位级别:

三级甲等

Institution/hospital:

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

河南

市(区县):

Country:

China

Province:

He'nan

City:

单位(医院):

河南省中医院

单位级别:

三级甲等

Institution/hospital:

Henan Hospital of traditional Chinese Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

河南

市(区县):

郑州

Country:

China

Province:

He'nan

City:

Zhengzhou

单位(医院):

河南省人民医院

单位级别:

三级甲等

Institution/hospital:

Henan Provincial People's Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

临床症状

指标类型:

次要指标

Outcome:

Clinical symptoms

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

1年急性加重住院次数

指标类型:

主要指标

Outcome:

Times of acute aggravation hospitalization in one year

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

6 分钟步行试验(6MWT)

指标类型:

次要指标

Outcome:

6-minute walk test

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼吸困难评分

指标类型:

次要指标

Outcome:

Dyspnea 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:

生存质量

指标类型:

主要指标

Outcome:

Quality of life

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺功能: DLCO%、FVC

指标类型:

主要指标

Outcome:

Lung function: DLCO%, FVC

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

安全性指标

指标类型:

副作用指标

Outcome:

Safety index

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:

尿液

组织:

Sample Name:

urine

Tissue:

人体标本去向

使用后保存

说明

研究完成后保存3年

Fate of sample 

Preservation after use

Note:

标本中文名:

血液

组织:

Sample Name:

blood serum

Tissue:

人体标本去向

使用后保存

说明

研究完成后保存3年

Fate of sample 

Preservation after use

Note:

征募研究对象情况:

正在进行

Recruiting

年龄范围:

最小 40
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):

由第三方进行中央分层区组随机

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

Central stratified block randomization will be adopted and performed by a third party.

盲法:

由第三方(江苏法迈生科技有限公司)完成设盲,且在整个研究过程中,研究者、受试者、数据采集者、结局指标评价者均不能获取盲底。

Blinding:

Blind method for investigaters, subjects, data collectors and outcome evaluators.

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):

以学术论文的形式进行公开。

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

The raw data will be made public with academic papers.

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:

所有的原始数据填到CRF表中,并和盲底一起在随机化电子系统中被第三方独立管理。

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

All the data will be recorded in the case record form as raw materials. The data will also be recorded in the electronic data capture with original records of allocations, and administered by a third party.

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

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):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above