我要注册
立即登录
中文/English
平台介绍|试验检索|关于我们|新闻公告
基于肠道微生态对线粒体供能的影响探讨加味芪榔方治疗药物依赖性便秘的疗效研究

注册号：

Registration number：

ITMCTR2200005525

最近更新日期：

Date of Last Refreshed on：

2022-01-11

注册时间：

Date of Registration：

2022-01-11

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

基于肠道微生态对线粒体供能的影响探讨加味芪榔方治疗药物依赖性便秘的疗效研究

Public title：

Based on the effect of intestinal microecology on mitochondrial energy supply, this study explored the efficacy of Jiawei Qilang prescription in the treatment of drug-dependent constipation

注册题目简写：

English Acronym：

研究课题的正式科学名称：

加味芪榔方通过改善肠道微生态治疗药物依赖性便秘的临床评价

Scientific title：

Clinical evaluation of modified Qilang prescription in the treatment of drug-dependent constipation by improving intestinal microecology

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：

ChiCTR2200055507 ; ChiMCTR2200005525

申请注册联系人：

张克慧

研究负责人：

李勇

Applicant：

Zhang Kehui

Study leader：

Li Yong

申请注册联系人电话：

Applicant telephone：

19921842930

研究负责人电话：

Study leader's telephone：

021-56639828

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：

285593405@qq.com

研究负责人电子邮件：

Study leader's E-mail：

liyong_SCI@126.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：

上海市静安区芷江中路274号上海市中医医院

研究负责人通讯地址：

上海市静安区芷江中路274号上海市中医医院

Applicant address：

No.274, Zhijiang Middle Road, Jing 'an District, Shanghai

Study leader's address：

274 Middle Zhijiang Road

申请注册联系人邮政编码：

Applicant postcode：

200071

研究负责人邮政编码：

Study leader's postcode：

200071

申请人所在单位：

上海市中医医院

Applicant's institution：

Shanghai Municipal Hospital 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：

2018SHL-KYYS-22

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：

上海市中医医院伦理委员会

Name of the ethic committee：

Shanghai Municipal Hospital of Traditional Chinese Medicine Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2018/5/30 0:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

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：

上海市中医医院

Primary sponsor：

Shanghai Municipal Hospital of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

上海市静安区芷江中路274号

Primary sponsor's address：

No.274, Zhijiang Middle Road, Jing 'an District, Shanghai

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：

上海市

单位(医院)：

上海市中医医院

具体地址：

上海市静安区芷江中路274号上海市中医医院

Institution
hospital：

Shanghai Municipal Hospital of Traditional Chinese Medicine

Address：

No.274, Zhijiang Middle Road, Jing 'an District, Shanghai

经费或物资来源：

上海市科学技术委员会

Source(s) of funding：

Science and Technology Commission of Shanghai Municipality

研究疾病：

便秘

研究疾病代码：

Target disease：

Constipation

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：

其它

Others

研究目的：

1）通过随机双盲双模拟对照研究，临床上证实加味芪榔方的有效性及安全性。初步探讨加味芪榔方在中医治疗药物依赖性便秘的客观性和优势，并为加味芪榔方在药物依赖性便秘中应用的进一步研究奠定基础，准备专利转化。2）通过肠道菌群检测分析比较药物依赖性便秘患者与健康人及治疗前后的肠道微生态特征，评估药物依赖性便秘患者肠道微生态改变情况，初步探寻加味芪榔方对药物依赖性便秘患者肠道菌群的调控作用。

Objectives of Study：

The main results are as follows: 1) through a randomized double-blind double-simulation controlled study, the effectiveness and safety of Jiawei Qilang prescription were confirmed in clinic. To explore the objectivity and advantages of modified Qilang prescription in the treatment of drug-dependent constipation in traditional Chinese medicine, and to lay a foundation for further research on the application of modified Qilang prescription in drug-dependent constipation and prepare for patent conversion. 2) the intestinal microecological characteristics of patients with drug-dependent constipation and healthy people before and after treatment were analyzed and compared, and the changes of intestinal microecology of patients with drug-dependent constipation were evaluated. to explore the regulatory effect of Jiawei Qilang recipe on intestinal microflora in patients with drug-dependent constipation.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

气阴两虚证的中医诊断标准（参照中华中医药学会脾胃病分会《便秘中医诊疗专家共识意见(2017)》）主症：排便次数减少，排便周期延长，或粪质艰难，便下困难，或排便无力，出而不畅。次症：气虚：1)乏力懒言;2)纳呆；3）腹胀阴虚：1)手足心热;2)形体消瘦;3)心烦少眠。符合至少2项主症，2项次证，气虚和阴虚各一项；各疾病症状分级量化结合中药新药临床研究指导原则及相关原则制定。2.2西医诊断标准：(1)便秘:诊断标准参考罗马IV诊断标准制定，具体如下:在过去的6个月内至少有12周(不必连续)发生以下两项或两项以上的情况:①1／4以上的排便费力;②1／4以上的排便干结或坚硬（参照Bristol粪便性状1型或2型）;③1／4以上的排便时有排便不尽感;③1／4以上排便时有肛门直肠的梗阻或阻塞感;④1／4以上排便时要额外帮助(手指抠挖、盆底按摩);⑤每周自发排粪＜3次;⑥没有排稀溏便现象，且不足以诊断肠易激综合征。（2）1年中间断或持续服用含蒽醌类成分泻药大于6个月的病史，病程超过1年。（3）其他:经相关检查排除器质性疾病。2.3纳入标准符合药物依赖性便秘的西医诊断标准；中医辨证为气阴两虚证；年龄在18周岁至70周岁（包括18周岁及70周岁）；自愿参加本实验并同意签署知情同意。

Inclusion criteria

The TCM diagnostic criteria of Qi-Yin deficiency syndrome (refer to the consensus of TCM experts in diagnosis and treatment of constipation of spleen and stomach Disease Branch of Chinese Society of traditional Chinese Medicine (2017)) the main symptoms are as follows: reduced defecation frequency, prolonged defecation cycle, or difficult fecal quality, difficulty in defecation, or weakness in defecation. Secondary symptoms: Qi deficiency: 1) fatigue and lazy speech; 2) stupefaction; 3) abdominal distension and yin deficiency: 1) hand and foot heart heat; 2) body weight loss; 3) worry and lack of sleep. In line with at least 2 main symptoms, 2 secondary syndromes, qi deficiency and yin deficiency, each disease symptom grading and quantification combined with the guiding principles and related principles of clinical research of new drugs of traditional Chinese medicine. 2.2 Western diagnostic criteria: (1) constipation: the diagnostic criteria are established with reference to the Rome IV diagnostic criteria, as follows: at least 12 weeks in the past 6 months (not necessarily continuous) the following two or more things have occurred: strenuous defecation of more than 11pm; dry knot or hardness of defecation above 21mm4 (refer to Bristol stool trait 1 or 2); and incomplete defecation in defecation of more than 31mm4. 3There is a sense of anorectal obstruction or obstruction when defecation above 41p4, extra help (finger picking, pelvic floor massage) is needed when defecation is above 41x4, spontaneous defecation is less than 3 times a week, and there is no loose defecation, and it is not enough to diagnose irritable bowel syndrome. (2) the history of discontinuation or continuous use of laxatives containing anthraquinones in one year was more than 6 months, and the course of disease was more than 1 year. (3) others: organic diseases were excluded by relevant examination. 2.3 the inclusion criteria meet the diagnostic criteria of western medicine for drug-dependent constipation; the syndrome differentiation of traditional Chinese medicine is deficiency of both qi and yin; the age is from 18 to 70 years old (including 18 and 70 years old); voluntarily participate in this experiment and agree to sign informed consent.

排除标准：

合并消化道等器质性病变、心血管、脑血管、肝、肾、造血系统等严重原发疾病；合并精神及有精神疾病史者；年龄小于18岁或大于70岁者；不能耐受本研究药物治疗的患者；怀孕、哺乳期妇女；研究中认为有任何不适宜入选的情况

Exclusion criteria：

Complicated with organic diseases such as digestive tract, cardiovascular, cerebrovascular, liver, kidney, hematopoietic system and other serious primary diseases; patients with a history of mental illness or mental illness; patients less than 18 years old or more than 70 years old; patients who could not tolerate drug treatment in this study; pregnant and lactating women; any situation considered unsuitable for selection in the study

研究实施时间：

Study execute time：

从From 2021-01-01

至To      2022-01-01

征募观察对象时间：

Recruiting time：

从From 2021-01-01

至To      2022-01-01

干预措施：

Interventions：

组别：

治疗组

样本量：

80

Group：

treatment group

Sample size：

干预措施：

加味芪榔方+杜密克模拟剂治疗

干预措施代码：

Intervention：

jiawei qilang power+Duphalacsimulation agent treatment

Intervention code：

组别：

对照组

样本量：

80

Group：

control group

Sample size：

干预措施：

加味芪榔方模拟剂+杜密克治疗

干预措施代码：

Intervention：

jiawei qilang simulation power+Duphalac

Intervention code：

样本总量 Total sample size ： 160

研究实施地点：

Countries of recruitment
and research settings：

测量指标：

Outcomes：

指标中文名：

粪便高通量16S rDNA测序及分析

指标类型：

主要指标

Outcome：

High-throughput 16SrDNA sequencing and analysis of feces

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

5-羟色胺

指标类型：

主要指标

Outcome：

5-hydroxytryptamine

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：

Feces

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：

血清

组织：

Sample Name：

Serum

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）：

由不参与临床试验的上海中医药大学统计学人员对药物进行随机分配编盲，使用SPSS21.0统计软件播种随机种子产生随机数字，将同一对子中的2个研究对象按照随机数字大小随机分配到A组和B组。同时产生A、B两套药物编号，A组患者服用A药，B组患者服用B药。

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

The drugs were randomly assigned and blinded by the statisticians of Shanghai University of traditional Chinese Medicine who did not participate in the clinical trial. SPSS21.0 statistical software was used to sow random seeds to generate random numbers. Two subjects in the same pair were randomly assigned to&#

盲法：

双盲法设计包括一级设盲和二级设盲。由不参与临床试验的上海中医药大学统计学人员对药物进行随机分配编盲，使用SPSS21.0统计软件播种随机种子产生随机数字，将同一对子中的2个研究对象按照随机数字大小随机分配到A组和B组。同时产生A、B两套药物编号，A组患者服用A药，B组患者服用B药。实际编盲例数为160例，分为两组，治疗组和对照组各80例。编盲过程根据上海中医药大学附属市中医医院临床试验药物编码操作规范要求进行，并有详细的编盲过程记录。同时，为每个受试者药盒上写上编号，并为每个病例准备了一个应急信件。信封标有病人的患者配对号及药物编码，信封内密封的信纸注明了所属组别和该组别患者具体所服用的药物种类和剂量，供紧急揭盲时用。

Blinding：

Double-blind design includes primary blindness and secondary blindness. The drugs were randomly assigned and blinded by the statisticians of Shanghai University of traditional Chinese Medicine who did not participate in the clinical trial. SPSS21.0 statistical software was used to sow random seeds to generate random numbers. Two subjects in the same pair were randomly assigned to group An and group B according to the size of random numbers. Two sets of drug numbers An and B were produced at the same time. Patients in group A took medicine An and patients in group B took medicine B. The actual number of blind cases was 160, which were divided into two groups: treatment group (n = 80) and control group (n = 80). The blindness process was carried out according to the code of operation of clinical trial drug coding in the affiliated Hospital of Shanghai University of traditional Chinese Medicine, and the blindness process was recorded in detail. At the same time, a number was written on each subject's medicine box and an emergency letter was prepared for each case. The envelope is marked with the patient's matching number and drug code, and the sealed letter paper in the envelope indicates the group to which the patient belongs and the specific type and dose of drugs taken by the patient in that group, which can be used in case of emergency blindness detection.

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）：

非公开

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

Private

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：

Case Record Form

数据管理委员会：

Data Managemen Committee：

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):

返回
平台信息
平台简介
关于我们
试验注册
常见问题
伦理审查
公共服务
试验检索
参与我们
国际传统医学临床试验注册平台 京ICP备07032215号-5 提示：推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统