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请与我们联系上传伦理批件 基于肠道微生态探讨痰湿调体方干预痰湿体质的临床观察研究
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注册号:

Registration number:

ChiCTR2000040342 

最近更新日期:

Date of Last Refreshed on:

2020-12-23 

注册时间:

Date of Registration:

2020-11-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

请与我们联系上传伦理批件 基于肠道微生态探讨痰湿调体方干预痰湿体质的临床观察研究 

Public title:

Clinical Observation and Research on the Intervention of Phlegm-Dampness Constitution by Tan Shi Tiao Ti Decoction Based on Intestinal Microecology 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于肠道微生态探讨痰湿调体方干预痰湿体质的临床观察研究 

Scientific title:

Clinical Observation and Research on the Intervention of Phlegm-Dampness Constitution by Tan Shi Tiao Ti Decoction Based on Intestinal Microecology 

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:

ChiMCTR2000004092 

申请注册联系人:

马晗 

研究负责人:

王琦 

Applicant:

mahan 

Study leader:

Wang Qi 

申请注册联系人电话:

Applicant telephone:

19800315231 

研究负责人电话:

Study leader's telephone:

010-64286867 

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:

17862968903@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wangqi710@126.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:

北京市朝阳区北三环中路11号北京中医药大学 

研究负责人通讯地址:

北京市朝阳区北三环东路11号北京中医药大学 

Applicant address:

Beijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing 

Study leader's address:

Beijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing 

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:

北京中医药大学第三附属医院 

Applicant's institution:

Beijing University of Chinese Medicine Third Affiliated Hospital 

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:

2017BZHYLL0502 

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:

北京中医药大学医学与实验动物伦理委员会 

Name of the ethic committee:

The Medicine and Experimental Animal Ethics Committee of Beijing University of Chinese Medicine  

伦理委员会批准日期:

Date of approved by ethic committee:

2017-09-20 

伦理委员会联系人:

赵燕 

Contact Name of the ethic committee:

Zhao Yan 

伦理委员会联系地址:

北京市朝阳区北三环东路11号北京中医药大学科技处 

Contact Address of the ethic committee:

Division of Science and Technology, Beijing University of Chinese Medicine, 11 North Third Ring Road East, Chaoyang District, Beijing, China  

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 15201484830 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

yanzh3232@126.com 

研究实施负责(组长)单位:

北京中医药大学第三附属医院 

Primary sponsor:

Beijing University of Chinese Medicine Third Affiliated Hospital 

研究实施负责(组长)单位地址:

北京市朝阳区安定门外小关街51号 

Primary sponsor's address:

51 Xiaoguan Street, Andingmenwai, Chaoyang District, Beijing, 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):

北京

市(区县):

北京

Country:

China

Province:

Beijing

City:

Beijing

单位(医院):

北京中医药大学第三附属医院

具体地址:

北京市朝阳区安定门外小关街51号

Institution
hospital:

Beijing University of Chinese Medicine Third Affiliated Hospital

Address:

51 Xiaoguan Street, Andingmenwai, Chaoyang District, Beijing, China

经费或物资来源:

国家自然科学基金面上项目(NO.8197150969) 

Source(s) of funding:

General Project of the National Natural Science Foundation of China (No. 81730112)  

研究疾病:

痰湿体质 

Target disease:

Phlegm-dampness constitution 

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:

研究目的:

运用菌群基因组测序、靶向代谢组学等技术手段,阐明痰湿体质功能肠菌和胆汁酸谱的内在特征,为揭示痰湿体质易发代谢性疾病的生物学基础提供数据支持;运用肠系菌群移植、菌群厌氧培养等验证方法,对比干预前后痰湿体质调体关键菌株和胆汁酸谱的动态变化,阐释痰湿调体方改善痰湿体质代谢紊乱的作用机制。为临床进一步推广应用奠定研究基础,也为中医药实施肠道菌群调节的治疗策略,实现对代谢性疾病的有效防治提供科学依据。 

Objectives of Study:

The internal characteristics of intestinal bacteria and bile acid spectrum of phlegm-dampness constitutive function were clarified by means of genome sequencing and targeted metabolomics, so as to provide data support for revealing the biological basis of metabolic diseases prone to phlegm-dampness constitutive disease.By using the methods of intestinal flora transplantation and anaerobic culture, the dynamic changes of the key strains and bile acid spectrum of phlegm-dampness body regulation before and after intervention were compared, and the mechanism of improving the metabolic disorder of phlegm-dampness body regulation was explained.It lays the research foundation for further clinical popularization and application, and also provides scientific basis for TCM to implement the treatment strategy of intestinal flora regulation and realize the effective prevention and treatment of metabolic diseases. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

⑴按照研究诊断标准,体质判定为平和体质健康人群或单纯痰湿体质人群; ⑵年龄范围:18≤年龄≤60(年龄按照筛选调查日期与出生日期的差值计算),性别不限; ⑶受试者知情同意,并签署知情同意书; 

Inclusion criteria

⑴Classified balance constitution and phlegm-dampness constitution according to the China Association of Chinese Medicine (CACM) standards 2009 (Classification and Determination of Constitution in Traditional Chinese Medicine, No:ZZYXH/T157-2009); ⑵Aged 18-60 years old male and female; ⑶Agreeing to join the study and signing the informed consent; 

排除标准:

⑴有明显兼夹体质者; ⑵哺乳或妊娠的妇女; ⑶有代谢性疾病、胃肠道疾病、心脑血管疾病或其他明确诊断疾病者; ⑷研究对象在采样前一个月内有服用抗生素、胃肠动力药、微生态调节剂史; ⑸近3个月内参与其他相关研究项目。 

Exclusion criteria:

⑴With apparent composite constitution type; ⑵Pregnancy or lactation women; ⑶Having Metabolic diseases, gastrointestinal diseases, cardio-cerebrovascular diseases or other diseases with definite diagnosis; ⑷Antibiotic usage in last 1 month. Other foods or drugs affecting intestinal flora usage in last 1 month, e.g. gastrointestinal prokinetic agents, micro-ecological modulators; ⑸Having attend other research projects in 3 months after join this research. 

研究实施时间:

Study execute time:

From2021-01-01To 2022-01-01 

征募观察对象时间:

Recruiting time:

From2020-11-01To 2021-01-01 

干预措施:

Interventions:

组别:

平和质组

样本量:

30

Group:

Balanced constitution

Sample size:

干预措施:

无干预

干预措施代码:

Intervention:

No

Intervention code:

组别:

痰湿质组

样本量:

30

Group:

Phlegm-dampness constitution

Sample size:

干预措施:

痰湿调体方

干预措施代码:

Intervention:

Tan Shi Tiao Ti decoction

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

北京中医药大学第三附属医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing University of Chinese Medicine Third Affiliated Hospital  

Level of the institution:

a Grade III Level A hospital 

测量指标:

Outcomes:

指标中文名:

中医体质量表得分

指标类型:

主要指标 

Outcome:

Score of Chinese Medicine Constitution 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:

甘油三酯

指标类型:

主要指标 

Outcome:

TG

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

空腹血糖

指标类型:

主要指标 

Outcome:

FPG

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总胆固醇

指标类型:

主要指标 

Outcome:

TC

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

低密度脂蛋白胆固醇

指标类型:

主要指标 

Outcome:

LDL-C

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

高密度脂蛋白胆固醇

指标类型:

主要指标 

Outcome:

HDL-C

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

糖化血红蛋白

指标类型:

次要指标 

Outcome:

HbA1c

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

空腹胰岛素

指标类型:

次要指标 

Outcome:

FINS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

载脂蛋白β

指标类型:

次要指标 

Outcome:

Apo-β

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

载脂蛋白α

指标类型:

次要指标 

Outcome:

Apo-α

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重

指标类型:

次要指标 

Outcome:

Weight

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体脂率

指标类型:

次要指标 

Outcome:

Body Fat Percentage

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:

腰围

指标类型:

次要指标 

Outcome:

Waistline

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

臀围

指标类型:

次要指标 

Outcome:

Hipline

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腰臀比

指标类型:

次要指标 

Outcome:

W/H

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重指数

指标类型:

次要指标 

Outcome:

Body Mass Index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胰岛素抵抗指数

指标类型:

次要指标 

Outcome:

HOMA-IR Index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肠道菌群结构测定

指标类型:

次要指标 

Outcome:

The composition of gut microbiota

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肠道菌群功能测定

指标类型:

次要指标 

Outcome:

The function of gut microbiota

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肠道菌群代谢

指标类型:

次要指标 

Outcome:

The metabolism of gut microbiota

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胆汁酸谱测定

指标类型:

次要指标 

Outcome:

Bile acid spectrometric determination

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

高血糖和低血糖事件

指标类型:

副作用指标 

Outcome:

Hyperglycemia and hypoglycemia events

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胰岛素抵抗指数

指标类型:

次要指标 

Outcome:

HOMA-IR Index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝功能

指标类型:

附加指标 

Outcome:

liver function

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肾功能

指标类型:

附加指标 

Outcome:

kidney function

Type:

Additional 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:

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 years
最大 Max age 60 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):

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

No

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

2022年,公开方式为论文发表

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

In 2022. Publication of paper is the way of 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:

由病例记录表记录数据,由ResMan平台进行电子数据采集和管理

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

Case Record Form (CRF) is used for data recording and ResMan is used for data management.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-11-28
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