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Study on the Clinical markers of children with constipation and the Therapeutic Effect of Xiaoji Tongbian Prescription on internal heat syndrome of constipation

注册号：

Registration number：

ITMCTR2000004131

最近更新日期：

Date of Last Refreshed on：

2020-09-25

注册时间：

Date of Registration：

2020-09-25

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

便秘患儿证候学生物标志物及小儿消积通便方治疗便秘食积内热证疗效评价研究

Public title：

Study on the Clinical markers of children with constipation and the Therapeutic Effect of Xiaoji Tongbian Prescription on internal heat syndrome of constipation

注册题目简写：

English Acronym：

研究课题的正式科学名称：

便秘患儿证候学生物标志物及小儿消积通便方治疗便秘食积内热证疗效评价研究

Scientific title：

Study on the Clinical markers of children with constipation and the Therapeutic Effect of Xiaoji Tongbian Prescription on internal heat syndrome of constipation

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：

ChiCTR2000038605 ; ChiMCTR2000004131

申请注册联系人：

胡钰

研究负责人：

赵霞

Applicant：

Huyu

Study leader：

Zhaoxia

申请注册联系人电话：

Applicant telephone：

+86 18036167321

研究负责人电话：

Study leader's telephone：

+86 13915994006

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：

xushichong2009@163.com

研究负责人电子邮件：

Study leader's E-mail：

zhaoxiahy@njucm.edu.cn

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：

江苏省南京市秦淮区汉中路155号

研究负责人通讯地址：

江苏省南京市秦淮区汉中路155号南京中医药大学附属医院

Applicant address：

155 Hanzhong Road, Qinhuai District, Nanjing, Jiangsu, China

Study leader's address：

155 Hanzhong Road, Qinhuai District, Nanjing, Jiangsu, 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：

南京中医药大学附属医院

Applicant's institution：

Affiliated Hospital of Nanjing University of 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：

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：

Name of the ethic committee：

伦理委员会批准日期：

Date of approved by ethic committee：

2013/8/26 0:00:00

伦理委员会联系人：

胡钰

Contact Name of the ethic committee：

18036167321

伦理委员会联系地址：

南京市秦淮区汉中路155号

Contact Address of the ethic committee：

155 Hanzhong Road, Qinhuai District, Nanjing, 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：

南京中医药大学附属医院

Primary sponsor：

Affiliated Hospital of Nanjing University of Chinese Medicine

研究实施负责（组长）单位地址：

江苏省南京市秦淮区汉中路155号南京中医药大学附属医院

Primary sponsor's address：

155 Hanzhong Road, Qinhuai District, Nanjing, Jiangsu, 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)：

江苏省

市(区县)：

Country：

China

Province：

Jiangsu

City：

单位(医院)：

南京中医药大学附属医院

具体地址：

江苏省南京市秦淮区汉中路155号南京中医药大学附属医院

Institution
hospital：

Affiliated Hospital of Nanjing University of Chinese Medicine

Address：

155 Hanzhong Road, Qinhuai District, Nanjing

经费或物资来源：

江苏省中医院课题

Source(s) of funding：

Project of Jiangsu Hospital of Traditional Chinese Medicine

研究疾病：

便秘

研究疾病代码：

Target disease：

Conspitation

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

非随机对照试验

Non randomized control

研究所处阶段：

Study phase：

I期临床试验

Phase I clinical trial

研究目的：

主要目的： （1）完成小儿消积通便方治疗便秘食积内热证有效性评价； （2）进一步明确该方对于治疗小儿便秘食积内热证的具体优势； （3）探索便秘患儿与健康儿童代谢组学差异，建立中医药治疗小儿便秘安全有效的治疗方案； （4）建立中医药治疗小儿便秘食积内热证安全有效的治疗方案。 次要目的： （1）主要根据临床症状观察不良事件发生的可能性，对其安全性作出评价。

Objectives of Study：

Main Purpose: (1) To complete the evaluation of the effectiveness of xiaoji Tongbian Prescription for treating internal heat syndrome of constipation; (2) To further clarify the specific advantages of this prescription for the treatment of constipation in children with internal heat syndrome; (3) To explore the metabolic differences between children with constipation and healthy children, and establish a safe and effective treatment program for children constipation with Traditional Chinese medicine; (4) To establish a safe and effective treatment program of TCM for the syndrome of internal heat of food accumulation in children with constipation. Secondary purpose: (1) To evaluate the safety of adverse events based on the observation of the possibility of occurrence of clinical symptoms.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

西医诊断标准 参照罗马Ⅳ便秘诊断标准（2016版）及《诸福棠实用儿科学》有关内容制定： 小于4岁婴幼儿，在1个月内必须包括以下至少2项： （1）排便次数为每周2次或更少。 （2）有粪便过度潴留史。 （3）有排便疼痛或排干硬粪便史。 （4）有排粗大粪便史。 （5）直肠存在大团粪块。 在学会如厕的儿童，可采用以下额外标准： （6）在学会如厕排便后，出现大便失禁至少每周1次。 （7）有排粗大粪便史，甚至可造成厕所堵塞。 儿童和青少年功能性便秘诊断标准：必须包括2项或2项以上，症状出现至少每周1次，持续至少一个月，不符合肠易激综合征的诊断标准： （1）年龄至少4岁的儿童，排便次数为每周2次或更少。 （2）大便失禁至少每周一次。 （3）有过粪便潴留被动姿势或过度忍受粪便潴留的病史。 （4）有排便疼痛或排干硬粪质的病史。 （5）直肠存在大团粪块。 （6）有排粗大粪便史，甚至可造成厕所堵塞。 （7）经过适度评估，症状不能完全用其他疾病表现来解释。 总结：１）排便间隔天数＞２ｄ，未使用泻剂的情况下排便次数＜３次／ｗ；２）大便干燥坚硬和／或有排便困难；３）病程≥1个月。患儿需同时具备以上３项。 中医便秘的诊断标准： 参照《中医儿科学》及《中医内科病证诊断疗效标准》制定： （1）排便间隔时间延长，二天以上一次，大便干燥或秘结不通，重者大便艰难，粪质干燥如栗； （2）便意频频，但难以排出或难以排净； （3）可伴有腹胀、腹痛、食欲不振或呕吐、烦躁、夜寐不安、夜间哭闹、生长发育迟缓等症。 （4）排除肠道器质性疾病。 患儿需至少具备第（1）项。 中医便秘食积内热证的证候诊断标准： 参照《中医儿科学》及《中医内科病证诊断疗效标准》制定： （1）大便干结，排出困难。 （2）舌质红或红绛，古苔薄黄或黄腻或黄厚腻。 （3）脉沉实或滑，或指纹紫滞。 （4）面赤身热，手足心热，唇红，口臭。 （5）伴腹胀或腹痛，夜卧不安。 （6）食欲不振，不思乳食，或恶心呕吐。 （7）小便黄赤。 治疗组纳入标准 （1）凡符合上述西医诊断标准者，治疗组需符合中医辨病辨证标准； （2）年龄在1～12岁之间，性别不限； （3）本次疾病期间未使用任何相关治疗药物； （4）知情同意，志愿受试。获得知情同意书过程应符合GCP规定。

Inclusion criteria

Diagnostic criteria of Western medicine With reference to the Roman IV constipation diagnosis standards (2016 edition) and "ZhuFuTang practical pediatrics" relevant content: Infants under 4 years of age must include at least 2 of the following items within 1 month: (1) The frequency of defecation is 2 times or less per week. (2) History of excessive fecal retention. (3) A history of painful defecation or hard excrement. (4) A history of heavy excrement. (5) There is a large fecal mass in the rectum. For children learning to use the toilet, the following additional criteria may be applied: (6) Having fecal incontinence at least once a week after learning to defecate in the toilet. (7) Having a history of heavy excrement, which may even cause a blockage of the toilet. Diagnostic criteria for functional constipation in children and adolescents: must include two or more items, symptoms appear at least once a week for at least one month, and do not meet the diagnostic criteria for irritable bowel syndrome: (1) For children aged at least 4 years, the frequency of defecation is 2 times a week or less. (2) Fecal incontinence at least once a week. (3) A history of fecal retention in a passive position or excessive fecal retention. (4) A history of painful defecation or hard excretion of feces. (5) There is a large fecal mass in the rectum. (6) Having a history of heavy excrement, which may even cause a blockage of the toilet. (7) After a moderate assessment, symptoms cannot be fully explained by other manifestations of the disease. Summary: 1) days of defecation interval > 2d, defecation times < 3 times/w without laxative;2) Dry and hard stools and/or difficulty in defecating;3) Duration ≥1 month.Children should have all three of the above. Diagnostic criteria of constipation in Traditional Chinese medicine: According to the "Chinese Medicine Pediatrics" and "Chinese Medicine Internal Disease Syndrome Diagnosis and Curative Effect Standard" : (1) The interval time of defecation is extended, two days to once, the stool is dry or tight, the heavy stool is difficult, the fecal material is dry like chestnut; (2) frequent, but difficult to discharge or discharge; (3) May be accompanied by abdominal distension, abdominal pain, loss of appetite or vomiting, irritability, restless night sleep, crying at night, growth retardation and other diseases. (4) Elimination of organic intestinal diseases. Children should have at least item (1). Criteria for diagnosis of internal heat syndrome of constipation in Chinese medicine: According to the "Chinese Medicine Pediatrics" and "Chinese Medicine Internal Disease Syndrome Diagnosis and Curative Effect Standard" : (1) Stool dry, discharge difficulty. (2) Red or red purple tongue, thin yellow or yellow greasy or thick greasy ancient moss. (3) The pulse is solid or slippery, or fingerprint purple stagnation. (4) Hot face, warm hands and feet, red lips and bad breath. (5) Accompanied by abdominal distension or abdominal pain, restless night. (6) Loss of appetite, lack of milk, or nausea and vomiting. (7) Urinate yellow. Treatment group inclusion criteria (1) For those who meet the above diagnostic criteria of Western medicine, the treatment group shall meet the criteria of disease differentiation and syndrome differentiation of Traditional Chinese medicine; (2) Between the ages of 1 and 12, regardless of gender; (3) No relevant medication was used during the illness; (4) Informed consent and volunteer.The process of obtaining informed consent shall comply with GCP regulations.

排除标准：

（1）不符合病例纳入标准。 （2）因肠道器质性病变（如巨结肠，乙状结肠冗长证，直肠狭窄）、内分泌疾病、代谢疾病、神经系统疾病导致便秘。 （3）合并心脑血管、肝肾和造血系统等原发性疾病及神经精神疾病； （4）资料不全，未按规定用药或擅自中断治疗，无法判定疗效； （5）对本中药成份过敏者； （6）年龄＜1岁和年龄＞12岁者； （7）正在参加其他药物临床试验的患者。

Exclusion criteria：

(1) Do not meet the inclusion criteria for cases. (2) Constipation is caused by organic intestinal diseases (such as megacolon, sigmoid syndrome, rectal stricture), endocrine diseases, metabolic diseases, and neurological diseases. (3) Combined with cardiovascular and cerebrovascular, liver and kidney, hematopoietic system and other primary diseases and neuropsychiatric diseases; (4) The efficacy cannot be determined due to incomplete data, failure to take medication as prescribed or interruption of treatment without authorization; (5) Allergic to the traditional Chinese medicine ingredients; (6) age < 1 and age > 12;

研究实施时间：

Study execute time：

从From 2019-12-01

至To      2022-08-31

征募观察对象时间：

Recruiting time：

从From 2020-10-15

至To      2022-04-30

干预措施：

Interventions：

组别：

治疗组

样本量：

54

Group：

Experimental group

Sample size：

干预措施：

小儿消积通便方

干预措施代码：

Intervention：

Decoction of Xiaojitongbian

Intervention code：

组别：

对照组

样本量：

54

Group：

control group

Sample size：

干预措施：

王氏保赤丸

干预措施代码：

Intervention：

Wangshi Baochi Pil

Intervention code：

样本总量 Total sample size ： 113

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

江苏

市(区县)：

Country：

China

Province：

Jiangsu

City：

单位(医院)：

南京中医药大学附属医院

单位级别：

三甲医院

Institution/hospital：

Affiliated Hospital of Nanjing University of Chinese Medicine

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

大便性状

指标类型：

主要指标

Outcome：

stool property

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

排便频次

指标类型：

主要指标

Outcome：

Defecation frequency

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：

尿液

组织：

Sample Name：

urine

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：

stool

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 1 岁
Min age years
最大 12 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）：

无随机

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

No random

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）：

2022年09月 结题报告

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

Final report in September 2022

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：

①研究者必须在诊治受试者同时书写研究病历，保证数据记录及时、完整、准确、真实。②研究病历做任何有证据的更正时只能划线，旁注改后的数据，由研究者签名并注明日期，不得擦涂、覆盖原始记录。③门诊受试者的原始化验单粘贴在研究病历上，住院受试者的原始化验单粘贴在住院病历上。门诊与住院受试者的化验结果均需填写至研究病历的“理化检查结果报告表”。

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

(1) The investigator must write the study medical records while diagnosing and treating the subjects to ensure that the data records are timely, complete, accurate and true.(2) Any evidence-based corrections to the medical records should only be underlined. The corrected data should be signed and dated by the researcher, and the original records should not be erased or overwritten.The original laboratory sheet of the out-patient subjects shall be pasted on the study medical record, and the original laboratory sheet of the in-patient subjects shall be pasted on the in-patient medical record.Laboratory results of both outpatient and inpatient subjects shall be filled in the physical and chemical Examination Results Report Form in the study medical record.

数据管理委员会：

Data Managemen Committee：

有

Yes

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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