ChiCTR2300067254 版本V1.1 版本创建时间2023/05/12 20:20:39 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2300067254 

最近更新日期：

Date of Last Refreshed on：

 2023-01-01 20:45:10 

注册时间：

Date of Registration：

 2023-01-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Investigation about the Prevalence, Chinese Medicine Syndrome Types and its Underlying Mechanism of Long COVID among Diabetic Patien

Public title：

Investigation about the Prevalence, Chinese Medicine Syndrome Types and its Underlying Mechanism of Long COVID among Diabetic Patients in Hong Kong

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Investigation about the Prevalence, Chinese Medicine Syndrome Types and its Underlying Mechanism of Long COVID among Diabetic Patients in Hong Kong

Scientific title：

Investigation about the Prevalence, Chinese Medicine Syndrome Types and its Underlying Mechanism of Long COVID among Diabetic Patients in Hong Kong

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：

申请注册联系人：

Wong Hoi Ki 

研究负责人：

Bian Zhaoxiang 

Applicant：

Wong Hoi Ki 

Study leader：

Bian Zhaoxiang 

申请注册联系人电话：

Applicant telephone：

 +86 19896541996

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：

 kkihwong@163.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)：

Applicant 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：

School of Chinese Medicine, Hong Kong Baptist University

Applicant's institution：

School of Chinese Medicine, Hong Kong Baptist University

研究负责人所在单位：

School of Chinese Medicine, Hong Kong Baptist University

Affiliation of the Leader：

School of Chinese Medicine, Hong Kong Baptist University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 REC/22-23/0220

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

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：

 2022-12-23 00:00:00

伦理委员会联系人：

Dr Cheung, King-Ho

Contact Name of the ethic committee：

Dr Cheung, King-Ho

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：

 Not stated

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：

School of Chinese Medicine, Hong Kong Baptist University

Primary sponsor：

School of Chinese Medicine, Hong Kong Baptist University

研究实施负责（组长）单位地址：

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

Primary sponsor's address：

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

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong SAR

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：

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

Institution
hospital：

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

Address：

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

经费或物资来源：

Chinese Medicine Development Fund of the Hong Kong Special Administrative Region Government (22B2/012A)

Source(s) of funding：

Chinese Medicine Development Fund of the Hong Kong Special Administrative Region Government (22B2/012A)

研究疾病：

Diabetes mellitus, long COVID  

Target disease：

Diabetes mellitus, long COVID

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

析因分组（即根据危险因素或暴露因素分组） 

Study design：

Factorial 

研究目的：

1) To determine the prevalence of long COVID in diabetes mellitus (DM) patients after Omicron infection, compared with non-diabetics. 2) To investigate the common traditional Chinese medicine (TCM) syndrome types of long COVID in DM patients after Omicron infection. 3) To characterize the relationship between different traditional Chinese medicine (TCM) syndrome types of long COVID and the gut microbiota composition in diabetes mellitus (DM) patients after Omicron infection.  

Objectives of Study：

1) To determine the prevalence of long COVID in diabetes mellitus (DM) patients after Omicron infection, compared with non-diabetics. 2) To investigate the common traditional Chinese medicine (TCM) syndrome types of long COVID in DM patients after Omicron infection. 3) To characterize the relationship between different traditional Chinese medicine (TCM) syndrome types of long COVID and the gut microbiota composition in diabetes mellitus (DM) patients after Omicron infection.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

a. Phase 1 Study:
- Aged 18 years or above.
- The first diagnosis of COVID-19 by PCR test/RAT dated between February 18, 2022 and May 6, 2022.
- Either:
1) Non-diabetics before COVID-19; or
2) DM patients diagnosed by physician(s) before COVID-19.
- Fully understand what is involved in this study and give documented consent to participate in the study.
- Able to understand and be able to follow written and oral instructions in Chinese.
b. Phase 2 Study:
- Aged 18-65 years.
- The latest diagnosis of COVID-19 by PCR test/RAT at least 4 weeks; and the latest test(s) had shown negative result(s) prior to the commencement of the study.
- Either:
1) Non-diabetics before COVID-19; or
2) DM patients diagnosed by physician(s) before COVID-19
- Meet the diagnostic criteria of long COVID: at least one new, returning, or ongoing health problem(s) experienced by people four or more weeks after the initial coronavirus infection.
- Have experienced at least one long COVID symptom(s) within the past 7 days.
- Verbally communicable.
- Fully understand what is involved in this study and give documented consent to participate in the study.
- Able to understand and be able to follow written and oral instructions in Chinese.
c. Phase 3 Study:
- Aged 18-65 years.
- The latest diagnosis of COVID-19 by PCR test/RAT at least 4 weeks; and the latest test(s) had shown negative result(s) prior to the commencement of the study.
- Either:
1) Non-diabetics before COVID-19; or
2) DM patients diagnosed by physician(s) before COVID-19
- Meet the diagnostic criteria of long COVID: at least one new, returning, or ongoing health problem(s) experienced by people four or more weeks after the initial coronavirus infection.
- Have experienced at least one long COVID symptom(s) within the past 7 days.
- Verbally communicable.
- Have completed the 2nd phase (face-to-face TCM syndrome type diagnosis) of the study.
- Falls into one of the five most common TCM syndrome types of long COVID with reference to the result(s) of the phase 2 study.
- Fully understand what is involved in this study and give documented consent to participate in the study.
- Able to understand and be able to follow written and oral instructions in Chinese.

Inclusion criteria

a. Phase 1 Study:
- Aged 18 years or above.
- The first diagnosis of COVID-19 by PCR test/RAT dated between February 18, 2022 and May 6, 2022.
- Either:
1) Non-diabetics before COVID-19; or
2) DM patients diagnosed by physician(s) before COVID-19.
- Fully understand what is involved in this study and give documented consent to participate in the study.
- Able to understand and be able to follow written and oral instructions in Chinese.
b. Phase 2 Study:
- Aged 18-65 years.
- The latest diagnosis of COVID-19 by PCR test/RAT at least 4 weeks; and the latest test(s) had shown negative result(s) prior to the commencement of the study.
- Either:
1) Non-diabetics before COVID-19; or
2) DM patients diagnosed by physician(s) before COVID-19
- Meet the diagnostic criteria of long COVID: at least one new, returning, or ongoing health problem(s) experienced by people four or more weeks after the initial coronavirus infection.
- Have experienced at least one long COVID symptom(s) within the past 7 days.
- Verbally communicable.
- Fully understand what is involved in this study and give documented consent to participate in the study.
- Able to understand and be able to follow written and oral instructions in Chinese.
c. Phase 3 Study:
- Aged 18-65 years.
- The latest diagnosis of COVID-19 by PCR test/RAT at least 4 weeks; and the latest test(s) had shown negative result(s) prior to the commencement of the study.
- Either:
1) Non-diabetics before COVID-19; or
2) DM patients diagnosed by physician(s) before COVID-19
- Meet the diagnostic criteria of long COVID: at least one new, returning, or ongoing health problem(s) experienced by people four or more weeks after the initial coronavirus infection.
- Have experienced at least one long COVID symptom(s) within the past 7 days.
- Verbally communicable.
- Have completed the 2nd phase (face-to-face TCM syndrome type diagnosis) of the study.
- Falls into one of the five most common TCM syndrome types of long COVID with reference to the result(s) of the phase 2 study.
- Fully understand what is involved in this study and give documented consent to participate in the study.
- Able to understand and be able to follow written and oral instructions in Chinese.

排除标准：

Applicable to all phases of the study:
- Individuals with any serious commodities, such as cardio-/cerebro-vascular, respiratory, digestive, hepatic, renal, haematological disease(s) or abnormalities of other organs and systems; malignancies, major infectious disease(s) or neuropsychiatric disorders.
- Pregnant and nursing women as well as those who are suspected of being pregnant.
- Vulnerable adults (i.e. mentally or physically disabled who cannot take care of himself/herself）.
- Others whom the investigator or co-investigator considered to be inappropriate for enrolment (justifiable reason(s) must be provided).

Exclusion criteria：

Applicable to all phases of the study:
- Individuals with any serious commodities, such as cardio-/cerebro-vascular, respiratory, digestive, hepatic, renal, haematological disease(s) or abnormalities of other organs and systems; malignancies, major infectious disease(s) or neuropsychiatric disorders.
- Pregnant and nursing women as well as those who are suspected of being pregnant.
- Vulnerable adults (i.e. mentally or physically disabled who cannot take care of himself/herself）.
- Others whom the investigator or co-investigator considered to be inappropriate for enrolment (justifiable reason(s) must be provided).

研究实施时间：

Study execute time：

从 From 2023-01-01 00:00:00至 To 2023-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-01-01 00:00:00 至 To 2023-08-31 00:00:00

干预措施：

Interventions：

组别：

DM group

样本量：

 575

Group：

DM group

Sample size：

干预措施：

Study participants will complete an online questionnaire concerning their demographics, medical history as well as their COVID-19- and long COVID-related information as a self-reported measure of long COVID occurrence, symptoms, their types and severity.

干预措施代码：

Intervention：

Study participants will complete an online questionnaire concerning their demographics, medical history as well as their COVID-19- and long COVID-related information as a self-reported measure of long COVID occurrence, symptoms, their types and severity.

Intervention code：

组别：

Non-DM group

样本量：

 575

Group：

Non-DM group

Sample size：

干预措施：

Study participants will complete an online questionnaire concerning their demographics, medical history as well as their COVID-19- and long COVID-related information as a self-reported measure of long COVID occurrence, symptoms, their types and severity.

干预措施代码：

Intervention：

Study participants will complete an online questionnaire concerning their demographics, medical history as well as their COVID-19- and long COVID-related information as a self-reported measure of long COVID occurrence, symptoms, their types and severity.

Intervention code：

组别：

DM group

样本量：

 230

Group：

DM group

Sample size：

干预措施：

Participants will attend a face-to-face TCM syndrome type investigation during w

干预措施代码：

Intervention：

Participants will attend a face-to-face TCM syndrome type investigation during which their basic information, the data from the 4 diagnostic methods, including the clinical presentations, symptoms severity, tongue manifestations and pulse conditions and the TCM syndrome types are recorded.

Intervention code：

组别：

Non-DM group

样本量：

 230

Group：

Non-DM group

Sample size：

干预措施：

Participants will attend a face-to-face TCM syndrome type investigation during which their basic information, the data from the 4 diagnostic methods, including the clinical presentations, symptoms severity, tongue manifestations and pulse conditions and the TCM syndrome types are recorded.

干预措施代码：

Intervention：

Participants will attend a face-to-face TCM syndrome type investigation during which their basic information, the data from the 4 diagnostic methods, including the clinical presentations, symptoms severity, tongue manifestations and pulse conditions and the TCM syndrome types are recorded.

Intervention code：

组别：

DM group

样本量：

 115

Group：

DM group

Sample size：

干预措施：

All eligible candidates of the 2nd phase of the study are required to provide their stool samples along with their blood and urine samples. The research team will then review all screening assessments to confirm the participant’s eligibility. The data/samples from eligible candidates will be analyzed.

干预措施代码：

Intervention：

All eligible candidates of the 2nd phase of the study are required to provide their stool samples along with their blood and urine samples. The research team will then review all screening assessments to confirm the participant’s eligibility. The data/samples from eligible candidates will be analyzed.

Intervention code：

组别：

Non-DM group

样本量：

 115

Group：

Non-DM group

Sample size：

干预措施：

All eligible candidates of the 2nd phase of the study are required to provide their stool samples along with their blood and urine samples. The research team will then review all screening assessments to confirm the participant’s eligibility. The data/samples from eligible candidates will be analyzed.

干预措施代码：

Intervention：

All eligible candidates of the 2nd phase of the study are required to provide their stool samples along with their blood and urine samples. The research team will then review all screening assessments to confirm the participant’s eligibility. The data/samples from eligible candidates will be analyzed.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong SAR 

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：

 Qualified clinic of Chinese medicine 

Institution
hospital：

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

Level of the institution：

Qualified clinic of Chinese medicine

测量指标：

Outcomes：

指标中文名：

Occurrence of long COVID in DM patients and non-diabetics post COVID-19

指标类型：

主要指标

Outcome：

Occurrence of long COVID in DM patients and non-diabetics post COVID-19

Type：

Primary indicator

测量时间点：

Week 0

测量方法：

Measure time point of outcome：

Week 0

Measure method：

指标中文名：

Symptom types of long COVID in DM patients and non-diabetics post COVID-19

指标类型：

次要指标

Outcome：

Symptom types of long COVID in DM patients and non-diabetics post COVID-19

Type：

Secondary indicator

测量时间点：

Week 0

测量方法：

Measure time point of outcome：

Week 0

Measure method：

指标中文名：

Symptoms of long COVID in DM patients and non-diabetics post COVID-19

指标类型：

次要指标

Outcome：

Symptoms of long COVID in DM patients and non-diabetics post COVID-19

Type：

Secondary indicator

测量时间点：

Week 0

测量方法：

Measure time point of outcome：

Week 0

Measure method：

指标中文名：

Symptom severities of long COVID in DM patients and non-diabetics post COVID-19

指标类型：

次要指标

Outcome：

Symptom severities of long COVID in DM patients and non-diabetics post COVID-19

Type：

Secondary indicator

测量时间点：

Week 0

测量方法：

Measure time point of outcome：

Week 0

Measure method：

指标中文名：

Quality of life of DM patients and non-diabetics with long COVID

指标类型：

次要指标

Outcome：

Quality of life of DM patients and non-diabetics with long COVID

Type：

Secondary indicator

测量时间点：

Week 0

测量方法：

Measure time point of outcome：

Week 0

Measure method：

指标中文名：

TCM syndrome types of long COVID in DM patients and non-diabetics post COVID-19

指标类型：

次要指标

Outcome：

TCM syndrome types of long COVID in DM patients and non-diabetics post COVID-19

Type：

Secondary indicator

测量时间点：

Week 1

测量方法：

Measure time point of outcome：

Week 1

Measure method：

指标中文名：

Gut microbiota structure of DM patients and non-diabetics with long COVID

指标类型：

次要指标

Outcome：

Gut microbiota structure of DM patients and non-diabetics with long COVID

Type：

Secondary indicator

测量时间点：

Week 2

测量方法：

Measure time point of outcome：

Week 2

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

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：

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：

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：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

N/A, this is a 4-week observational study.

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

N/A, this is a 4-week observational study.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

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：

This is a 4-week observational study, in which subjects need to attend 1 online questionnaire, 1 assessment visit (face-to-face traditional Chinese medicine syndrome type investigation), provide 1 set of blood, stool, and urine sample. The blood test includes complete blood count (CBC), biochemistry test (renal function, liver function, electrolytes, etc.). The urinalysis includes visual exam (urine color and clarity), chemical exam (specific gravity, pH, bilirubin, urobilinogen, protein, glucose, ketones, hemoglobin and myoglobin, leukocyte esterase, nitrite, ascorbic acid), microscopic exam (red blood cells, white blood cells, epithelial cells, bacteria, yeast and parasites, casts, crystals). The stool analysis includes visual exam (color, consistency, amount, shape, odor, and the presence of mucus), microscopic examination, chemical tests, and microbiologic tests. All laboratory tests will be conducted in Hong Kong Chan & Hou Medical Laboratories Ltd. Original data of study forms will be entered and kept on file at the participating site on both paper and electronic version. 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. All the files are to be stored in numerical order and stored in a secure and accessible place. Participant files will be maintained in storage for a period of 5 years. In order to maximize subjects' compliance, we first run a thorough consent process for all participants by explaining the details of the study schedule, potential risks of assessments, and the responsibilities that need to be undertaken by subjects. Second, support and reassurance are provided during the whole study. Third, we will carefully scrutinize subjects to exclude ineligible and potentially low compliance individuals before allocation. Fourth, a direct telephone hotline, email account and social media account are established in order to optimize active communication with patients and to respond to enquiries. Participants who are inclined to drop out of the study will be contacted by the research team to resolve any issues that may prevent them from completing the study. Overall participant compliance will be assessed by the successful completion of online questionnaires, face-to-face TCM syndrome type investigation as well as provision of biological samples. Those who fail to complete these tasks within the specified timeframe will be followed up. Study candidates and enrolled participants will provide their data electronically which will then be uploaded to REDCap without manual data transfer: 1) individuals who are interested in participating in this study will complete an online/telephone screening questionnaire. The data will be synchronized to REDCap; 2) study candidates and enrolled participants will complete the online questionnaire on REDCap using their smartphones or via telephone survey by members of the research team. Members of the research team who conduct telephone screening interviews, in-person screening visits and study visits will complete the e-CRF in REDCap in real time. Data from external sources, e.g. clinical laboratories, will be received in the form of reports. The data will be manually entered into REDCap. Microbiome sequencing data will be directly downloaded from the sequencer and uploaded to REDCap. Two individuals from the School of Chinese medicine with expertise in clinical research and are not directly involved in this study will monitor the overall conduct of the study. Specifically, they will review the study progress including recruitment, retention, adverse events and study outcomes. They will also assess adherence to the research protocol, including the completion of informed consent and assessment processes, accuracy of data documentation, and specimen and data storage.

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

This is a 4-week observational study, in which subjects need to attend 1 online questionnaire, 1 assessment visit (face-to-face traditional Chinese medicine syndrome type investigation), provide 1 set of blood, stool, and urine sample. The blood test includes complete blood count (CBC), biochemistry test (renal function, liver function, electrolytes, etc.). The urinalysis includes visual exam (urine color and clarity), chemical exam (specific gravity, pH, bilirubin, urobilinogen, protein, glucose, ketones, hemoglobin and myoglobin, leukocyte esterase, nitrite, ascorbic acid), microscopic exam (red blood cells, white blood cells, epithelial cells, bacteria, yeast and parasites, casts, crystals). The stool analysis includes visual exam (color, consistency, amount, shape, odor, and the presence of mucus), microscopic examination, chemical tests, and microbiologic tests. All laboratory tests will be conducted in Hong Kong Chan & Hou Medical Laboratories Ltd. Original data of study forms will be entered and kept on file at the participating site on both paper and electronic version. 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. All the files are to be stored in numerical order and stored in a secure and accessible place. Participant files will be maintained in storage for a period of 5 years. In order to maximize subjects' compliance, we first run a thorough consent process for all participants by explaining the details of the study schedule, potential risks of assessments, and the responsibilities that need to be undertaken by subjects. Second, support and reassurance are provided during the whole study. Third, we will carefully scrutinize subjects to exclude ineligible and potentially low compliance individuals before allocation. Fourth, a direct telephone hotline, email account and social media account are established in order to optimize active communication with patients and to respond to enquiries. Participants who are inclined to drop out of the study will be contacted by the research team to resolve any issues that may prevent them from completing the study. Overall participant compliance will be assessed by the successful completion of online questionnaires, face-to-face TCM syndrome type investigation as well as provision of biological samples. Those who fail to complete these tasks within the specified timeframe will be followed up. Study candidates and enrolled participants will provide their data electronically which will then be uploaded to REDCap without manual data transfer: 1) individuals who are interested in participating in this study will complete an online/telephone screening questionnaire. The data will be synchronized to REDCap; 2) study candidates and enrolled participants will complete the online questionnaire on REDCap using their smartphones or via telephone survey by members of the research team. Members of the research team who conduct telephone screening interviews, in-person screening visits and study visits will complete the e-CRF in REDCap in real time. Data from external sources, e.g. clinical laboratories, will be received in the form of reports. The data will be manually entered into REDCap. Microbiome sequencing data will be directly downloaded from the sequencer and uploaded to REDCap. Two individuals from the School of Chinese medicine with expertise in clinical research and are not directly involved in this study will monitor the overall conduct of the study. Specifically, they will review the study progress including recruitment, retention, adverse events and study outcomes. They will also assess adherence to the research protocol, including the completion of informed consent and assessment processes, accuracy of data documentation, and specimen and data storage.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

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  2023-01-01 20:43:44