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Effect of quyushengxin recipe on intestinal microorganism in patients with ulcerative colitis

注册号：

Registration number：

ITMCTR1900002355

最近更新日期：

Date of Last Refreshed on：

2019-05-23

注册时间：

Date of Registration：

2019-05-23

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

祛瘀生新方对溃疡性结肠炎患者肠道微生物的影响

Public title：

Effect of quyushengxin recipe on intestinal microorganism in patients with ulcerative colitis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于肠道宏病毒组学研究祛瘀生新法调控溃疡性结肠炎的机制

Scientific title：

Based on intestinal macrovirus histology studying the mechanism of Quyushengxin to regulate ulcerative colitis

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：

ChiCTR1900023349 ; ChiMCTR1900002355

申请注册联系人：

杨豪杰

研究负责人：

王振宜

Applicant：

Haojie Yang

Study leader：

Zhenyi Wang

申请注册联系人电话：

Applicant telephone：

+86 19946001614

研究负责人电话：

Study leader's telephone：

+86 13601760317

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：

tonyhaojie@163.com

研究负责人电子邮件：

Study leader's E-mail：

drxinhuo@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：

上海市甘河路110号

研究负责人通讯地址：

上海市甘河路110号

Applicant address：

110 Ganhe Road, Shanghai, China

Study leader's address：

110 Ganhe Road, Shanghai, China

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岳阳中西医结合医院

Applicant's institution：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of T.C.M

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：

2017-020

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

上海中医药大学附属岳阳中西医结合医院伦理委员会

Name of the ethic committee：

Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of T.C.M

伦理委员会批准日期：

Date of approved by ethic committee：

1990/1/1 0:00:00

伦理委员会联系人：

郑莉

Contact Name of the ethic committee：

Li Zheng

伦理委员会联系地址：

上海市甘河路110号

Contact Address of the ethic committee：

110 Ganhe Road, Shanghai, 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：

上海中医药大学附属岳阳中西医结合医院

Primary sponsor：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of T.C.M

研究实施负责（组长）单位地址：

上海市甘河路110号

Primary sponsor's address：

110 Ganhe Road, Shanghai, 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)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海中医药大学附属岳阳中西医结合医院

具体地址：

上海市甘河路110号

Institution
hospital：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of T.C.M

Address：

110 Ganhe Road, Shanghai, China

经费或物资来源：

国家自然基金（青年）

Source(s) of funding：

National nature fund

研究疾病：

溃疡性结肠炎

研究疾病代码：

Target disease：

ulcerative colitis

Target disease code：

研究类型：

Study type：

基础科学研究

Basic Science

研究设计：

Study design：

析因分组（即根据危险因素或暴露因素分组）

Factorial

研究所处阶段：

Study phase：

其它

Others

研究目的：

在中医“祛瘀生新”理论指导下，采用临床疗效确切的祛瘀生新方（溃结2号方）为治疗手段，从肠道病毒、菌群的动态变化角度，运用宏病毒组学和宏基因组学技术 1.探讨祛瘀生新方调节肠道微生物的作用机理，为中医运用“祛瘀生新”学术思想治疗溃疡性结肠炎提供理论依据。 2.研究肠道尚未发现的病毒群体，并分析其在中药干预前后的不同病理阶段以及正常人体中差异，分析其可能产生的作用。 3.研究通过间接作用，由病毒（噬菌体）攻击肠道特定宿主细菌菌群导致发病的致病机理，以及祛瘀生新方的干预和调控作用，为中医治疗该病和早期预防疾病发生提供理论依据。

Objectives of Study：

Under the guidance of the theory of "quyu sheng xin" in traditional Chinese medicine, the quyu sheng xin recipe (kuijie no.2 recipe) with definite clinical efficacy was adopted as the treatment method. From the perspective of the dynamic changes of enterovirus and flora, the techniques of macroviromics and macrogenomics were applied 1. To explore the mechanism of quyusheng new prescription in regulating intestinal microorganism, so as to provide theoretical basis for the application of "quyusheng new" academic thought in the treatment of ulcerative colitis in traditional Chinese medicine. 2. Study the undiscovered intestinal virus population, and analyze its differences in different pathological stages before and after TCM intervention and in normal human body, and analyze its possible role. 3. To study the pathogenic mechanism of diseases caused by viruses (phages) attacking specific intestinal host bacterial flora through indirect effects, as well as the intervention and regulation effect of quyusheng new recipe, so as to provide theoretical basis for TCM treatment of the disease and early prevention of disease.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

正常志愿者组纳入标准： 1)平素身体健康,无各类既往病史； 2)排便规律通畅，粪质质软成形; 3)年龄18岁至65岁者； 4)对研究人员观察有良好的依从性，自愿参加，签订知情同意书。 溃疡性结肠炎组纳入标准： 1)临床症状、肠镜镜下表现、肠黏膜活检病理标本同时符合诊断标准者; 2)年龄18岁至65岁者； 3)改良Mayo评分系统评估溃疡性结肠炎活动度评分为小于等于10分者。 4)对研究人员观察有良好的依从性，自愿参加，签订知情同意书。

Inclusion criteria

Inclusion criteria for normal volunteers: 1) normal healthy without any previous medical history; 2) the defecation law is unobstructed and the fecal material is soft forming; 3) persons aged between 18 and 65 years; 4) good compliance with researchers' observation, voluntary participation, and signing of informed consent. Ulcerative colitis group inclusion criteria: 1) those with clinical symptoms, colonoscopy and intestinal mucosa biopsy pathological specimens meeting the diagnostic criteria at the same time; 2) persons aged between 18 and 65 years; 3) the activity score of ulcerative colitis evaluated by the modified Mayo scoring system is less than or equal to 10 points; 4) good compliance with researchers' observation, voluntary participation, and signing of informed consent.

排除标准：

正常志愿者组排除标准： 1)不符合纳入标准者； 2)妊娠或哺乳期妇女，过敏体质者。 溃疡性结肠炎组排除标准： 1)临床症状、肠镜镜下表现、肠黏膜活检病理标本其一不符合诊断标准者； 2)妊娠或哺乳期妇女，过敏体质及对观察药过敏者； 3)合并有心血管、脑血管、肝、肾和造血系统等严重原发性疾病，精神病患者； 4)有肠道狭窄、肠梗阻、肠穿孔、直肠息肉、中毒性结肠扩张、结肠癌、直肠癌及肛门疾病者;急性暴发型、重度患者； 5)未按规定用药，无法判定疗效或资料不全等影响疗效判断者。

Exclusion criteria：

Exclusion criteria for normal volunteers: 1) those who do not meet the inclusion criteria; 2) pregnant or lactating women with allergies. Ulcerative colitis group exclusion criteria: 1) clinical symptoms, colonoscopy findings, or pathological specimens of intestinal mucosa biopsy fail to meet the diagnostic criteria; 2) pregnant or lactating women, allergic constitution and allergic to the observed drugs; 3) patients with severe primary diseases of cardiovascular, cerebrovascular, liver, kidney and hematopoietic system; 4) patients with intestinal stenosis, intestinal obstruction, intestinal perforation, rectal polyps, toxic colonic dilatation, colon cancer, rectal cancer and anal diseases;Acute fulminant, severe patients; 5) the patient fails to use the medicine as prescribed, and the efficacy cannot be judged or the efficacy is affected by incomplete data.

研究实施时间：

Study execute time：

从From 2017-06-05

至To      2018-06-04

征募观察对象时间：

Recruiting time：

从From 2017-06-05

至To      2018-06-04

干预措施：

Interventions：

组别：

正常组

样本量：

8

Group：

Normal group

Sample size：

干预措施：

no

干预措施代码：

Intervention：

no

Intervention code：

组别：

溃疡性结肠炎组

样本量：

16

Group：

Treatment group

Sample size：

干预措施：

祛瘀生新方

干预措施代码：

Intervention：

quyushengxin recipe

Intervention code：

样本总量 Total sample size ： 24

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

China

Province：

Shanghai

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：

三甲

Institution/hospital：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of T.C.M

Level of the institution：

Tertiary A hospital

测量指标：

Outcomes：

指标中文名：

肠道菌群

指标类型：

主要指标

Outcome：

intestinal flora

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肠道病毒

指标类型：

主要指标

Outcome：

Enteric Virome

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疾病活动指数

指标类型：

主要指标

Outcome：

DAI

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：

粪便

组织：

Sample Name：

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 岁
Min age years
最大 岁
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）：

N/A

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

N/A

盲法：

N/A

Blinding：

N/A

是否共享原始数据：

IPD sharing：

是

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）：

ResMan临床试验公共管理平台

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

ResMan (www.medresman.org)

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：

数据管理的标准操作规程（Standard Operation Procedure, SOP）研究过程严格按照SOP进行。 数据的填写和录入:病历及病历记录表格作为原始记录不得更改，做任何更正时不得改变原记录，只能采用附加说明理由，由参加临床试验的医师签名并注明日期。认真记录患者的治疗情况对患者的依从性要做详细记录，对全部按时接受治疗有时遗漏等情况进行详细记录、说明。对试验中止的原因及与试验的关系如何等要认真记录，包括中止时的评价。对中途有患者自行退出试验的要明确记录原因并详细记录中止症状评价。患者未按时来院复诊应打电话、发信等问明理由，并调查事情经过等。 数据复核:研究者按临床试验方案进行数据复查检查可能漏填、错填的项目和度量衡单位的统一与否等。资料收集完成后中心的负责人、研究助理、监察员按各自的分工和责任校对资料收集的数量和质量对数据的完整性和准确性进行监督与检查。主持单位质控员定期和不定期抽查CRF如有误差应登记在案填写“检查问题报告表”并及时返回临床研究者进行更正。数据处理统计人员最后在数据录入前进一步全面核实和检查数据的完整性和准确性。数据录入和管理由专人负责建立专用数据库进行数据录入和管理应由二个数据管理员独立进行双份录入并校对。

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

Data management standard operating procedures (Standard, Operation, Procedure, SOP), the research process strictly in accordance with SOP. Data entry: medical records and medical records and fill in the record form as the original records shall not be changed, do not change the original record of any corrections, can only use the additional explanation by the signature of the doctor in the clinical trial and date. Careful record of the patient's treatment, the patient's compliance should be recorded in detail, all on time, receive treatment, sometimes missing, etc. detailed records, instructions. The reasons for the discontinuation of the test and the relationship between the test and the test should be recorded carefully, including the evaluation of the suspension. The reasons for the patient's withdrawal from the trial should be clearly recorded, and the symptom evaluation will be recorded in detail. Who did not come on time, hospital referral should call letters such as ask the reason, and to investigate the incident etc.. Data review: the researchers reviewed the data according to the clinical trial program, checked the items that might be missing and filled in, and whether the units of measurement and weights were unified or not. After the data collection has been completed, the head of the center, research assistants and supervisors supervise and inspect the completeness and accuracy of the data in accordance with their respective division of labor and responsibility, and the quantity and quality of the data collected. The quality control staff of the unit shall take regular and unscheduled CRF checks. If there is any error, they shall register and fill out the "examination report form" and return them to the clinical researcher for correction in a timely manner. Data processing, statisticians finally move forward in data entry, fully verify and check data integrity and accuracy. Data entry and management by the person responsible for the establishment of a dedicated database for data entry and management, should be two data managers independent double entry and proofreading.

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):

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