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Actions and the Mechanisms of MaZiRenWan (MZRW) for Functional Constipation and Constipation-Predominant Irritable Bowel Syndrome

注册号：

Registration number：

ITMCTR2100004417

最近更新日期：

Date of Last Refreshed on：

2021-02-08

注册时间：

Date of Registration：

2021-02-08

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

Actions and the Mechanisms of MaZiRenWan (MZRW) for Functional Constipation and Constipation-Predominant Irritable Bowel Syndrome

Public title：

A randomised, double-blind, placebo-controlled clinical trial to determine the effects of MaZiRenWan granules on functional constipation and constipation-predominant irritable bowel syndrome

注册题目简写：

English Acronym：

研究课题的正式科学名称：

A Multicenter, Randomized, Double-Blind, Placebo-Control Clinical Trial to Uncover the Actions and the Mechanisms of MaZiRenWan (MZRW) for Functional Constipation and Constipation-Predominant Irritable Bowel Syndrome

Scientific title：

A randomised, double-blind, placebo-controlled clinical trial to determine the effects of MaZiRenWan granules on functional constipation and constipation-predominant irritable bowel syndrome

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：

ITC RC/IHK/4/7

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：

ChiCTR2100043211 ; ChiMCTR2100004417

申请注册联系人：

张轩

研究负责人：

卞兆祥

Applicant：

Xuan Zhang

Study leader：

Zhaoxiang Bian

申请注册联系人电话：

Applicant telephone：

+852 13632178096

研究负责人电话：

Study leader's telephone：

+852 34112905

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：

zhangxuan87418@126.com

研究负责人电子邮件：

Study leader's E-mail：

bianzxiang@gmail.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：

Room 307, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong, China

研究负责人通讯地址：

Room 307, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong, China

Applicant address：

Room 307, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong, China

Study leader's address：

Room 307, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong, 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：

香港浸會大學賽馬會中醫藥學院

Applicant's institution：

Hong Kong Baptist 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：

REC/20-21/0545

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：

Research Ethics Committee, Hong Kong Baptist University

Name of the ethic committee：

Research Ethics Committee, Hong Kong Baptist University

伦理委员会批准日期：

Date of approved by ethic committee：

2021/8/26 0:00:00

伦理委员会联系人：

Research Ethics Committee, Hong Kong Baptist University

Contact Name of the ethic committee：

Research Ethics Committee, Hong Kong Baptist University

伦理委员会联系地址：

Research Office, Hong Kong Baptist University, Kowloon Tong, Hong Kong.

Contact Address of the ethic committee：

Research Office, Hong Kong Baptist University, Kowloon Tong, Hong Kong.

伦理委员会联系人电话：

Contact phone of the ethic committee：

+852 3411-6521

伦理委员会联系人邮箱：

Contact email of the ethic committee：

hkbu_rec@hkbu.edu.hk

研究实施负责（组长）单位：

Hong Kong Baptist University

Primary sponsor：

Hong Kong Baptist University

研究实施负责（组长）单位地址：

Hong Kong Baptist University Kowloon Tong Kowloon Hong Kong

Primary sponsor's address：

Hong Kong Baptist University Kowloon Tong Kowloon Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

Clinical Division, School of Chinese Medicine, Hong Kong Baptist University

具体地址：

1/F, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Kowloon Tong, Kowloon.

Institution
hospital：

Clinical Division, School of Chinese Medicine, Hong Kong Baptist University

Address：

1/F, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Kowloon Tong, Kowloon.

经费或物资来源：

Health@InnoHK Initiative Fund of the Hong Kong Special Administrative Region Government (ITC RC/IHK/4/7)

Source(s) of funding：

Health@InnoHK Initiative Fund of the Hong Kong Special Administrative Region Government (ITC RC/IHK/4/7)

研究疾病：

Functional Constipation and Constipation-Predominant Irritable Bowel Syndrome

研究疾病代码：

Target disease：

Functional Constipation and Constipation-Predominant Irritable Bowel Syndrome

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：

This study aims to determine 1) the efficacy and safety of MZRW in IBS-C patients; 2) whether and how gut microbiota mediates the ameliorative effects of MZRW in FC and IBS-C spectrum; and 3) whether MZRW will take effect on patients through modulating gut dysbiosis.

Objectives of Study：

Primary Objective: To determine the efficacy and safety of MZRW in both IBS-C and FC patients in excessive TCM Pattern. Secondary Objectives: 1) To determine the effect of MZRW on gut microbiota composition and functions; and 2) To determine the relationship between changes in gut microbiota and clinical presentation of FC and IBS-C in excessive TCM Pattern.

药物成份或治疗方案详述：

The experimental intervention MaZiRenWan (MZRW) granule (7.5g/sachet) was composed of six herbs, including Fructus Cannabis (Huo Ma Ren), Radix et Rhizoma Rhei (Da Huang), Semen Armeniacae Amarae (Ku Xing Ren), Radix Paeoniae Alba (Bai Shao), Cortex Magnolia Officinalis (Hou Pu), and Fructus Aurantii Immaturus (Zhi Shi). The placebo granules will be made from dextrin (76.03%), tea essence (23.61%), gardeniaflavin (0.02%) and caramel (0.34%) to achieve smell, taste, color and texture comparable to MZRW granules. The production of both MZRW and placebo granules will be performed by the Purapharm (Nanning) Pharmaceuticals Co. Ltd (46 Keyuan Dadao, Nanning High-tech Zone, Guangxi Province, China). The entire manufacturing process, from authenticating the raw materials to the final products, will be in strict compliance with the standards of Good Manufactory Practice (GMP) and Chinese Pharmacopoeia (2020 Edition). Patients are instructed to dissolve a sachet of granules in 150ml of hot water; and to take the solution orally twice daily, after breakfast and dinner.

Description for medicine or protocol of treatment in detail：

This randomised, double-blind, placebo-controlled clinical trial will test the hypothesis that granules of MaZiRenWan (MZRW), a traditional Chinese herbal medicine formula, will have same efficacy in alleviating functional constipation (FC) and constipation-predominant irritable bowel syndrome (IBS-C) in individuals in excessive Traditional Chinese Medicine (TCM) Pattern (Heat and/or Qi stagnant) by modulating the gut microbiota that improves gut motility function. Participants in the FC (N=90) and IBS-C (N=90) cohorts will be randomly assigned to the treatment or placebo group in a 1:1 ratio, followed by 8 weeks of intervention and 8 weeks of follow-up. Throughout the study, all participants will record their bowel movement, evaluate constipation-related symptoms and provide stool samples for gut microbiota profiling.

纳入标准：

1. FC subjects: 1) Meet the diagnostic criteria for functional constipation based on Rome IV criteria; 2) Aged 18 to 65 years; 3) Signed an informed Consent Form (ICF); 4) Complete spontaneous bowel movement (CSBM) <= 2 times/week (CSBM is defined by feeling of complete passage of stool and without the use of laxatives or enemas within 24 hours); 5) Meet protocol-defined e-Diary completion compliance and agree to refrain from making any new, major life-style changes that may affect FC symptoms; 6) No clinical significance of colonoscopy examination findings. 2. IBS-C subjects: 1) The diagnostic criteria for constipation-predominant irritable bowel syndrome based on Rome IV criteria; 2) Aged 18 to 65 years; 3) Signed an informed Consent Form (ICF); 4) Complete spontaneous bowel movement (CSBM) <= 2 times/week (CSBM is defined by feeling of complete passage of stool and without the use of laxatives or enemas within 24 hours); 5) Abdominal pain intensity: weekly average of worst daily (in past 24 hours) abdominal pain score of >= 3.0 on a 0 to 10 point scale; 6) Irritable bowel syndrome-symptom severity score (IBS-SSS) >= 175.34; 7) Meet protocol-defined e-Diary completion compliance and agree to refrain from making any new, major life-style changes that may affect IBS-C symptoms; 8) No clinical significance of colonoscopy examination findings.

Inclusion criteria

a) All participants: - Aged between 18 and 65 (inclusive) - Understand and be able to follow written and oral instructions in Chinese - Provide informed consent - CSBM ≤ 2 times/week (based on the 2-week e-diary in screening) - Clinical diagnosed with constipation with excessive Pattern based on the Traditional Chinese Medicine (TCM) theory (Table 2) b) FC group only: - Clinically diagnosed with FC based on the ROME IV criteria - CSBM ≤ 2 times/week (based on the 2-week e-diary in screening) c) IBS-C group only: - Clinically diagnosed with IBS-C based on the ROME IV criteria - CSBM ≤ 2 times/week (based on the 2-week e-diary in screening) - Abdominal pain intensity: weekly average of the worst daily (in the past 24 hours) abdominal pain score of ≥3.0 on a 0 to 10 point scale - Irritable bowel syndrome-symptom severity score (IBS-SSS) ≥175 ROME IV criteria for IBS-C and FC are provided in the protocol. Any three of the following chief symptom manifestations of Heat and/or Qi stagnation: (1) Dry and hard stools; (2) Difficult bowel movements; (3) Abdominal distension, with or without tenderness; (4) Belching; (5) Dry mouth or halitosis; (6) Red tongue with dry and/or yellow coating; and (7) Wiry pulse.

排除标准：

Both IBS-C and FC subjects: 1) Drug-induced or secondary causes of constipation; 2) Recent history of mushy or watery stools within one month; 3) Known diagnosis of inflammatory bowel disease, celiac disease, microscopic colitis or other gut inflammatory condition; 4) Must use drugs that may adversely affect the study result during the study period (including but not limited to antibiotic, steroid, analgesic drug, neuromodulator, prebiotic, symbiotic, or probiotic drugs); 5) Severe depression and/or anxiety level (Zung Self-rating Depression Scale (SDS)>= 70 and/or Zung Self-rating Anxiety Scale (SAS) >= 60, and/or Hamilton depression rating scale (HAM-D) >= 19 and/or Hamilton anxiety rating scale (HAM-A) >= 25); 6) Clinical significance of laboratory or imaging tests findings; 7) Allergy to Chinese herbal medicine; 8) Prior medical history of abdominal surgeries within one year; 9) Pregnancy or plans to pregnant or breast-feeding with the study time frame; 10) Frequent alcohol consumption (>= 3 times per week and/or >= 2 drinks categories per session and/or >=3 drinks categories per weekly) consumption; 11) Vulnerable adults; 12) Any other disease(s), condition(s) or habit(s) that would interfere with completion of the study, or in the judgment of the investigator that the patients condition would potentially interfere compliance to this study or would adversely affect study outcomes.

Exclusion criteria：

- Drug-induced or secondary causes of constipation - Recent history of mushy or watery stools within one month - Known diagnosis of inflammatory bowel disease, celiac disease, microscopic colitis or other gut inflammatory condition - Use of medications and/or supplements that may confound the study outcomes (including but not limited to antibiotics, steroid, analgesic drug, neuromodulator, prebiotics, symbiotics, or probiotics) - Severe depression and/or anxiety level (Zung Self-rating Depression Scale (SDS)≥70 and/or Zung Self-rating Anxiety Scale (SAS) ≥60) - Clinically significant colonoscopy or sigmoidoscopy examination findings within the past 5 years - Clinically significant laboratory or imaging findings - Known allergic reactions to the ingredients in MZRW and/or placebo - Abdominal surgeries within the past year (except laparoscopic appendectomy) - Pregnancy, breastfeeding or plan to become pregnant with the study timeframe - Frequent alcohol consumption (≥3 times per week) - Vulnerable adults (i.e. mentally or physically disabled to take care of himself/herself) - Any disease(s), condition(s) or habit(s) deemed by the investigators that would prevent participation in the study, e.g. participation in past or active clinical research, at the discretion of the investigators - Any disease(s), condition(s) or habit(s) deemed by the investigators that would compromise the individuals ability to complete the study, e.g. serious psychiatric conditions, at the discretion of the investigators

研究实施时间：

Study execute time：

从From 2021-05-01

至To      2023-12-31

征募观察对象时间：

Recruiting time：

从From 2021-10-29

至To      2022-12-31

干预措施：

Interventions：

组别：

MZRW for IBS-C group

样本量：

45

Group：

MZRW for IBS-C group

Sample size：

干预措施：

MZRW granule

干预措施代码：

Intervention：

MZRW granule

Intervention code：

组别：

Placebo for FC group

样本量：

45

Group：

Placebo for FC group

Sample size：

干预措施：

MZRW placebo granule

干预措施代码：

Intervention：

MZRW placebo granule

Intervention code：

组别：

Placebo for IBS-C group

样本量：

45

Group：

Placebo for IBS-C group

Sample size：

干预措施：

MZRW placebo granule

干预措施代码：

Intervention：

MZRW placebo granule

Intervention code：

组别：

MZRW for FC group

样本量：

45

Group：

MZRW for FC group

Sample size：

干预措施：

MZRW granule

干预措施代码：

Intervention：

MZRW granule

Intervention code：

样本总量 Total sample size ： 180

研究实施地点：

Countries of recruitment
and research settings：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

Hong Kong Baptist University HK Island Wei Ke Qiang Chinese Medicine Specialty Clinic

单位级别：

Institution/hospital：

Hong Kong Baptist University HK Island Wei Ke Qiang Chinese Medicine Specialty Clinic

Level of the institution：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

Hong Kong Baptist University Chinese Medicine Specialty Centre

单位级别：

Institution/hospital：

Hong Kong Baptist University Chinese Medicine Specialty Centre

Level of the institution：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

Hong Kong Baptist University Mr. & Mrs. Chan Hon Yin Chinese Medicine Specialty Clinic and Good Clinical Practice Centre

单位级别：

Institution/hospital：

Hong Kong Baptist University Mr. & Mrs. Chan Hon Yin Chinese Medicine Specialty Clinic and Good Clinical Practice Centre

Level of the institution：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

Haven of Hope – Hong Kong Baptist University Chinese Medicine Specialty Clinic

单位级别：

Institution/hospital：

Haven of Hope – Hong Kong Baptist University Chinese Medicine Specialty Clinic

Level of the institution：

测量指标：

Outcomes：

指标中文名：

Change from baseline in 8-week irritable bowel syndrome-symptom severity score (IBS-SSS) score in IBS-C group

指标类型：

次要指标

Outcome：

IBS symptom severity, based on the scores of irritable bowel syndrome-symptom severity score (IBS-SSS) in the IBS-C group

Type：

Secondary indicator

测量时间点：

from baseline to treatment period, 8 weeks

测量方法：

IBS-SSS asks the severity of abdominal pain, frequency of abdominal pain, severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life over the past 10 days. Subjects respond to each question on a 100-point visual analogue scale, the range of total score is 0-500.

Measure time point of outcome：

baseline and Weeks 4, 8 and 16

Measure method：

IBS-SSS is a validated questionnaire that assesses the severity of abdominal pain, frequency of abdominal pain, severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life over the past 10 days. Participants respond to each question on a 100-point visual analogue scale,&#3

指标中文名：

The CSBM respond rate

指标类型：

次要指标

Outcome：

The CSBM respond rate

Type：

Secondary indicator

测量时间点：

8 weeks intervention period and 8 weeks follow-up period

测量方法：

Measure time point of outcome：

weekly from Week 9 to 16

Measure method：

A CSBM responder is defined as a patient who meets the CSBM responder criterion (i.e., a mean increase of CSBM≥1/week compared with CBSM at baseline). A spontaneous bowel movement (SBM) is defined as a bowel movement without laxative use in the preceding 24 hours.

指标中文名：

Change from baseline in 8-week CSBM and SBM frequency rate

指标类型：

次要指标

Outcome：

Spontaneous Bowel Movement (SBM) frequency

Type：

Secondary indicator

测量时间点：

baseline and 8-week treatment period

测量方法：

The change from baseline in 8-week CSBM frequency (i.e., average weekly CSBM frequency over the 8 weeks of the treatment period). The change from baseline in 8-week SBM frequency (i.e., average weekly SBM frequency over the 8 weeks of the treatment period).

Measure time point of outcome：

weekly from baseline to Week 16

Measure method：

The change from baseline in 8-week SBM frequency (i.e., average weekly SBM frequency during the interventional period). Baseline of weekly SBM will be the average between Week -2 and Week 0.

指标中文名：

指标类型：

次要指标

Outcome：

Colonic transit time (CTT)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

baseline and Week 8

Measure method：

By tracking the location and extent of elimination of radiopaque markers, CTT allows the quantification of colonic transit time that indicates motility function of the colon

指标中文名：

指标类型：

次要指标

Outcome：

Fecal microbiota structure

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

baseline and Weeks 0.5, 1, 2, 4, 8, 8.5, 9, 12 and 16

Measure method：

Longitudinal profiling of fecal microbiota will allow correlation analysis to examine the relationship between changes in gut microbiota and, bowel movements and constipation-related symptoms to explore the role of gut microbiota in medicating the treatment effect.

指标中文名：

Change from baseline in 8-week Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire and Patient Assessment of Constipation Quality of Life (PAC-QoL) questionnaire

指标类型：

次要指标

Outcome：

Constipation symptoms and quality of life, based on the scores of Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire and Patient Assessment of Constipation Quality of Life (PAC-QoL) questionnaire, respectively.

Type：

Secondary indicator

测量时间点：

from baseline to treatment period, 8 weeks

测量方法：

PAC-SYM is an assessment of the symptoms of constipation, it includes stool symptoms, rectal symptoms, and abdominal symptoms. PAC-QoL is a brief but comprehensive assessment of burden of constipation on patients’ functioning and well-being.

Measure time point of outcome：

baseline and Weeks 4, 8 and 16

Measure method：

PAC-SYM is an assessment of the symptoms of constipation, it includes stool symptoms, rectal symptoms, and abdominal symptoms. PAC-QoL is a brief but comprehensive assessment of burden of constipation on patients’ functioning and well-being.

指标中文名：

The Complete Spontaneous Bowel Movement (CSBM) respond rate

指标类型：

主要指标

Outcome：

The Complete Spontaneous Bowel Movement (CSBM) respond rate

Type：

Primary indicator

测量时间点：

from baseline to treatment period, 8 weeks

测量方法：

Measure time point of outcome：

from baseline to treatment period, 8 weeks

Measure method：

This endpoint is based on the FDA guidance for industry for clinical evaluation of drugs as treatments for irritable bowel syndrome

指标中文名：

指标类型：

次要指标

Outcome：

Abnormal result rate in glucose breath test

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

baseline and Week 8

Measure method：

The glucose breath test is a surrogate marker of small intestinal bacterial activity. An abnormal result of glucose breath test is defined as a rise in hydrogen of ≥20 p.p.m. and/or methane levels ≥10 p.p.m. by at the end of the 90-min test

指标中文名：

Abdominal Pain Weekly Responder in IBS-C group

指标类型：

次要指标

Outcome：

Abdominal Pain Responder rate in the IBS-C group

Type：

Secondary indicator

测量时间点：

8 weeks intervention period and 8 weeks follow-up period

测量方法：

Measure time point of outcome：

weekly from baseline to Week 16

Measure method：

Abdominal pain at its worst (in the last 24 hours) is assessed daily by participants on an 11-point numerical rating scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain

指标中文名：

指标类型：

次要指标

Outcome：

Symptoms of depression and anxiety, based on the scores of Zung’s Self-rating Depression Scale (SDS) and Zung’s Self-rating Anxiety Scale (SAS), respectively.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

baseline and Week 4, 8 and 16

Measure method：

Zung’s Self-rating Depression Scale (SDS) and Zung’s Self-rating Anxiety Scale (SAS) are two norm-referenced scales that can evaluate the severity of depression and anxiety.

指标中文名：

指标类型：

次要指标

Outcome：

Colonic mucosal microbiota structure

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

baseline and Week 8

Measure method：

Profiling the colonic mucosal microbiota will allow the examination of mucosa-adherent microbiota that may be functionally different from gut luminal microbiota. Baseline profiles will be determined from the samples collected during colonoscopy at screening.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

stool

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：

标本中文名：

Biopsy samples

组织：

Sample Name：

Biopsy samples

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：

Blood

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：

urine

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：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 65 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）：

Block randomization will be carried out in a 1:1 ratio in both groups according to the sequence generated with Random Allocation Software (Version 1.0.0).

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

Block randomization will be carried out in a 1:1 ratio in the IBS-C and FC groups respectively, with a block size of 10. The computer-generated randomization sequence will be generated by a randomisation center that not involved in the study and be kept in opaque sealed envelopes.

盲法：

Double-blinded. Treatment assignments will not reveal and will be blinded to patients and the investigator (outcome assessor) until the whole study is completed.

Blinding：

This will be a double-blind study. Both the investigational and placebo products will be labelled “Chinese Herbal Medicine Formula for FC/IBS-C clinical research”, in both Chinese and English, on the package. Treatment assignments will be blinded to both the participants and the investigators (including the outcome assessors) until the whole study is completed.

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）：

We will use REDCap online system to store and share IPD data.

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

We will use REDCap online system to store and share IPD data.

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：

We will use REDCap, a secure web application for building and managing online surveys and databases, to store our electronic data. PI and RAs will use electronic case report form (eCRF) to record patients’ information during the whole study. In addition, patients need to use Mycap, a mobile application for participants, to complete their e-diary and self-scale questionnaires.

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

We will use REDCap, a secure web application for building and managing online surveys and databases, to store our electronic data. PI and RAs will use electronic case report form (eCRF) to record patients’ information during the whole study. In addition, patients need to use Mycap, a mobile application for participants, to complete their e-diary and self-scale questionnaires.

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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