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A randomized, double-blind, parallel controlled trial for Zhizhu prescription in the treatment of slow transit constipation

注册号：

Registration number：

ITMCTR2000003380

最近更新日期：

Date of Last Refreshed on：

2020-06-07

注册时间：

Date of Registration：

2020-06-07

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

枳术方治疗慢传输型便秘的随机、双盲、阳性药物平行对照临床研究

Public title：

A randomized, double-blind, parallel controlled trial for Zhizhu prescription in the treatment of slow transit constipation

注册题目简写：

English Acronym：

研究课题的正式科学名称：

枳术方治疗慢传输型便秘的随机、双盲、阳性药物平行对照临床研究

Scientific title：

A randomized, double-blind, parallel controlled trial for Zhizhu prescription in the treatment of slow transit 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：

ChiCTR2000033653 ; ChiMCTR2000003380

申请注册联系人：

刘鹏林

研究负责人：

刘鹏林

Applicant：

Liu Penglin

Study leader：

Liu Penglin

申请注册联系人电话：

Applicant telephone：

+86 18661809006

研究负责人电话：

Study leader's telephone：

+86 18661809006

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：

kong-22277@163.com

研究负责人电子邮件：

Study leader's E-mail：

kong-22277@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：

山东省青岛市黄岛区五台山路1677号

研究负责人通讯地址：

山东省青岛市黄岛区五台山路1677号

Applicant address：

1677 Wutaishan Road, Huangdao District, Qingdao, Shandong, China

Study leader's address：

1677 Wutaishan Road, Huangdao District, Qingdao, Shandong, 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：

青岛大学附属医院

Applicant's institution：

The Affiliated Hospital of Qingdao University

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：

QYFYKYLL 731311920

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：

青岛大学附属医院医学伦理委员会

Name of the ethic committee：

Medical ethics committee of affiliated hospital of Qingdao university

伦理委员会批准日期：

Date of approved by ethic committee：

2020/5/7 0:00:00

伦理委员会联系人：

李环廷

Contact Name of the ethic committee：

Li Huanting

伦理委员会联系地址：

山东省青岛市市南区江苏路16号

Contact Address of the ethic committee：

16 Jiangsu Road, Shinan District, Qingdao, Shandong, 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：

青岛大学附属医院

Primary sponsor：

The Affiliated Hospital of Qingdao University

研究实施负责（组长）单位地址：

山东省青岛市黄岛区五台山路1677号

Primary sponsor's address：

1677 Wutaishan Road, Huangdao District, Qingdao, Shandong, 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)：

山东省

市(区县)：

青岛市

Country：

China

Province：

Shandong

City：

Qingdao

单位(医院)：

青岛大学附属医院

具体地址：

山东省青岛市黄岛区五台山路1677号

Institution
hospital：

The Affiliated Hospital of Qingdao University

Address：

1677 Wutaishan Road, Huangdao District

经费或物资来源：

山东省中医药科技发展计划

Source(s) of funding：

Development plan of traditional Chinese medicine science and technology in shandong province

研究疾病：

慢传输型便秘

研究疾病代码：

Target disease：

slow transit 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：

将枳术方与现有西药的有效性和安全性进行对比。总结该药治疗“虚型”结肠慢传输型便秘患者便秘相关症状及生活质量的改善程度，明确枳术方相比于目前治疗的临床优势，为形成中医治疗结肠慢传输型便秘的治疗路径奠定基础。

Objectives of Study：

The efficacy and safety of Zhizhu prescription were compared with the existing western medicine.To summarize the constipation related symptoms and improvement degree of life quality of patients with "deficiency" colon slow transit constipation treated with this drug, to clarify the clinical advantages of Zhizhu Prescription compared with the current treatment, and to lay a foundation for the formation of the treatment path of TCM for colon slow transit constipation.

药物成份或治疗方案详述：

设计随机双盲、阳性药物平行对照临床试验，设置治疗组与对照组，治疗组：枳术方治疗组，中药复方枳术方颗粒剂：生白术70g，枳实30g。用法：每次1包，每日2次，早晚用热开水约100ml冲溶。琥珀酸普芦卡必利模拟片（用法用量同西药对照组）；对照组：琥珀酸普芦卡必利片 2mg，口服，1次/d。中药复方颗粒模拟剂（用法用量同中药治疗组），以4周作为1疗程，随访1月以观察便秘主要症状的改善程度。

Description for medicine or protocol of treatment in detail：

A randomized double-blind, positive drug parallel control clinical trial was designed. The treatment group and the control group were set up. The treatment group: the treatment group of zhizhu prescription; the Chinese herbal compound zhizhu prescription granule: 70g of Raw atractylodes; 30g of immature bitter orange. Usage: 1 packet per time, 2 times a day, morning and night with hot water about 100ml rinse solution. Plucapride succinate simulation tablets (the same dosage as the western medicine control group); Control group: Plecapride succinate 2mg, oral, once per day. The simulated agent of Compound Chinese medicine granules (the dosage and usage of the same Chinese medicine treatment group) was used as a course of treatment for 4 weeks, followed up for 1 month to observe the improvement degree of main symptoms of constipation.

纳入标准：

（1）符合罗马Ⅳ标准诊断标准及中医虚秘诊断； （2）年龄在18-80周岁之间，性别不限（育龄期妇女在研究期间需采取避孕措施）； （3）配合治疗，能详细追问到患者病史并填写有关病史的评分量表； （4）末次其他治疗方式结束时间与此次研究治疗间隔时间＞１周； （5）同意在治疗期间不使用任何对胃肠蠕动功能有影响的食物或药物； （6）同意接受治疗过程，并签署知情同意书。

Inclusion criteria

(1) Patient meets the diagnostic criteria of Rome IV and the diagnosis of deficiency syndrome of traditional Chinese medicine; (2) Aged 18 to 80 years old (women of childbearing age need to take contraceptive measures during the study period); (3) The patient can cooperate with the treatment, and the doctor can obtain the patient's detailed history and fill in the score scale of the history; (4) the interval between the end time of the last other treatment and treatment of this study is more than 1 week; (5) patients agree not to use any food or drugs that affect gastrointestinal peristalsis during treatment; (6) patients agree to accept the treatment process and sign an informed consent form.

排除标准：

（1）年龄在18岁以下或80岁以上的患者； （2）孕期及哺乳期的女性； （3）对本研究中药物过敏者； （4）出口梗阻型便秘患者及肠易激综合征者； （5）治疗前１周内或治疗过程中服用过其它促排便药物者； （6）有心血管、泌尿、造血、内分泌系统和恶性肿瘤等严重原发性疾病者，有酒精、药物滥用病史及精神病患者； （7）检查证实有肠道器质性病变（如克罗恩病、结肠息肉及肠结核等）所致肠道狭窄者或有腹部手术史者； （8）未按规定服药，致疗效无法判定者，或因生活环境经常变动等因素易造成失访者。

Exclusion criteria：

(1) women during pregnancy and lactation; (2) those who are allergic to the drugs in this study; (3) Patients with outlet obstruction constipation and irritable bowel syndrome; (4) Those who have taken other defecation promoting drugs within 1 week before treatment or during treatment; (5) Patients with serious primary diseases such as cardiovascular,urinary, hematopoietic, endocrine system and malignant tumors, and patients with a history of alcohol and drug abuse and psychosis; (6) Patients with intestinal stenosis caused by organic lesions (such as Crohn's disease, colonic polyps and intestinal tuberculosis) or those with a history of abdominal surgery; (7) Fail to take medicine according to the regulation, cause curative effect cannot judge, or because the life environment often changes and other factors easily cause the loss of visitors.

研究实施时间：

Study execute time：

从From 2020-06-03

至To      2021-12-31

征募观察对象时间：

Recruiting time：

从From 2020-06-03

至To      2021-12-31

干预措施：

Interventions：

组别：

对照组

样本量：

40

Group：

control group

Sample size：

干预措施：

琥珀酸普芦卡必利片

干预措施代码：

Intervention：

Plucapride succinate tablets

Intervention code：

组别：

治疗组

样本量：

40

Group：

Experimental group

Sample size：

干预措施：

中药复方枳术方颗粒剂

干预措施代码：

Intervention：

Chinese herbal compound Zhizhufang Granules

Intervention code：

样本总量 Total sample size ： 80

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

山东省

市(区县)：

青岛市

Country：

China

Province：

Shandong

City：

Qingdao city

单位(医院)：

青岛大学附属医院

单位级别：

三甲医院

Institution/hospital：

the affiliated hospital of qingdao university

Level of the institution：

Tertiary A Hospital

国家：

中国

省(直辖市)：

山东省

市(区县)：

青岛市

Country：

China

Province：

Shandong

City：

Qingdao city

单位(医院)：

青岛大学附属医院

单位级别：

三甲医院

Institution/hospital：

the affiliated hospital of qingdao university

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

Bristol大便性状量表

指标类型：

主要指标

Outcome：

Bristol stool form scale (BSFS)

Type：

Primary indicator

测量时间点：

治疗前后、随访期

测量方法：

评分量表

Measure time point of outcome：

before and after treatment,during the follow-up

Measure method：

score scale

指标中文名：

中医证候疗效评分

指标类型：

主要指标

Outcome：

Therapeutic effect score of TCM syndromes

Type：

Primary indicator

测量时间点：

治疗前后、随访期

测量方法：

评分量表

Measure time point of outcome：

before and after treatment,during the follow-up

Measure method：

score scale

指标中文名：

便秘患者生存质量量表

指标类型：

主要指标

Outcome：

the Patient Assessment of Constipation Quality of Life (PAC-QOL)

Type：

Primary indicator

测量时间点：

治疗前后、随访期

测量方法：

评分量表

Measure time point of outcome：

before and after treatment,during the follow-up

Measure method：

score scale

指标中文名：

克利夫兰便秘评分

指标类型：

主要指标

Outcome：

Cleveland Clinic Constipation Score (CCS)

Type：

Primary indicator

测量时间点：

治疗前后、随访期

测量方法：

评分量表

Measure time point of outcome：

before and after treatment,during the follow-up

Measure method：

score scale

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 80 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）：

应用SAS软件

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

SAS software was used to generate random sequences

盲法：

本研究采用双盲法，治疗组与对照组的患者进行随机分组后将获得一个唯一的随机数字。药物及相应模拟药物保持外观一致，事先准备好整个治疗疗程的药量，将其分装在外观统一的大信封中，信封上记录随机数字(与患者获得的随机 数字保持一致)。分组后由工作人员根据受试者获得的随机号码发放给其相应的 信封。在此过程中，发放“药物”的工作人员对分组信息不知情，受试者对分组信息不知情。在治疗前后均采用盲法评价，由不知分组情况的临床观察者对患者进行病情资料的记录。数据统计分析由不了解分组情况的统计学专业人员 进行统计分析。本试验过程中受试者、研究者、评价者、统计者均对分组情况不知晓。

Blinding：

Double-blind method was used in this study, Patients in the treatment and control groups were randomly assigned to a unique random number.The drugs and the corresponding analog drugs keep the same appearance, prepare the amount of drugs for the whole course of treatment in advance, divide them into large envelopes with the same appearance, and record the random number on the envelope (consistent with the random number obtained by the patient).After grouping, the staff will give the corresponding envelopes according to the random Numbers obtained by the subjects.During this process, the "drug" dispenser was unaware of the grouping information, and the subjects were unaware of the grouping information.Patients were evaluated blinded before and after treatment, and their condition data were recorded by a clinical observer who did not know the grouping.Statistical analysis of data was conducted by statistical professionals who did not understand the grouping situation.In this study, the subjects, researchers, evaluators and statisticians were not aware of the grouping.

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）：

www.chictr.org.cn

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

www.chictr.org.cn

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（CRF）

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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