新冠病毒感染后医护人员免疫功能状况及“桑术养正饮”干预作用的预实验

注册号:

Registration number:

ITMCTR2024000372

最近更新日期:

Date of Last Refreshed on:

2024-09-04

注册时间:

Date of Registration:

2024-09-04

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

新冠病毒感染后医护人员免疫功能状况及“桑术养正饮”干预作用的预实验

Public title:

Pre experiment on the immune function of medical staff after COVID-19 infection and the intervention effect of "Sangshu Yangzheng Decoction"

注册题目简写:

English Acronym:

研究课题的正式科学名称:

新冠病毒感染后医护人员免疫功能状况及“桑术养正饮”干预作用的预实验

Scientific title:

Pre experiment on the immune function of medical staff after COVID-19 infection and the intervention effect of "Sangshu Yangzheng Decoction"

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:

申请注册联系人:

马大宝

研究负责人:

刘清泉

Applicant:

Dabao Ma

Study leader:

Qingquan Liu

申请注册联系人电话:

Applicant telephone:

18810956959

研究负责人电话:

Study leader's telephone:

+86 10 5217 6965

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:

18810956959@163.com

研究负责人电子邮件:

Study leader's E-mail:

liuqingquan2003@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:

北京市延庆区汇川街9号

研究负责人通讯地址:

北京市东城区美术馆后街23号

Applicant address:

9 Huichuan Street, Yanqing District, Beijing

Study leader's address:

23 Art Museum Back Street, Dongcheng District, Beijing, 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:

北京中医医院延庆医院

Applicant's institution:

Yanqing hospital, Beijing traditional Chinese medicine hospital

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:

2023BYL-B01-02

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:

北京中医医院延庆医院伦理委员会

Name of the ethic committee:

Yanqing Hospital Ethics Committee of Beijing Traditional Chinese Medicine Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2023/7/21 0:00:00

伦理委员会联系人:

沈雁鹏

Contact Name of the ethic committee:

Yanpeng Shen

伦理委员会联系地址:

北京市延庆区汇川街9号

Contact Address of the ethic committee:

9 Huichuan Street, Yanqing District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 135 0138 6652

伦理委员会联系人邮箱:

Contact email of the ethic committee:

yqxzyykjk@163.com

研究实施负责(组长)单位:

北京中医医院延庆医院

Primary sponsor:

Yanqing hospital, Beijing traditional Chinese medicine hospital

研究实施负责(组长)单位地址:

北京市延庆区汇川街9号

Primary sponsor's address:

9 Huichuan Street, Yanqing District, Beijing

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

延庆区

Country:

China

Province:

Beijing

City:

Yanqing

单位(医院):

北京中医医院延庆医院

具体地址:

北京市延庆区汇川街9号

Institution
hospital:

Yanqing hospital, Beijing traditional Chinese medicine hospital

Address:

9 Huichuan Street, Yanqing District, Beijing

经费或物资来源:

国家中医药多学科交叉创新团队项目ZYYCXTD-D-202201

Source(s) of funding:

National Multidisciplinary Innovation Team Project of Traditional Chinese Medicine ZYYCXTD-D-202201

研究疾病:

新冠感染后免疫功能

研究疾病代码:

Target disease:

Immune function after COVID-19 infection

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:

探索性研究/预试验

Pilot clinical trial

研究目的:

以新冠病毒感染后医护人员为研究对象,观察其新冠病毒感染后的免疫功能情况,评价“桑术养正饮”对于改善新冠病毒感染后医护人员免疫功能的有效性和安全性。

Objectives of Study:

Take the medical staff infected with COVID-19 as the research object, observe their immune function after COVID-19 infection, and evaluate the effectiveness and safety of "Sangzhu Yangzheng Decoction" for improving the immune function of medical staff infected with COVID-19

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

(1)2022年12月7日至12月31日期间SARS-CoV-2感染确诊史。 (2)年龄18至65岁; (3)自愿签署知情同意书。

Inclusion criteria

(1) Confirmed history of SARS-CoV-2 infection from December 7 to December 31, 2022. (2) Age 18 to 65 years old; (3) Voluntarily sign an informed consent form.

排除标准:

(1)合并有心肝肾、免疫和造血系统等严重疾病者。 (2)有重度情感障碍或精神病史或精神病家族史者; (3)怀孕或哺乳期妇女。 (4)因过敏等原因不能使用中药复方治疗患者。 (5)新冠病毒感染急性期患者(2周内再次感染新冠病毒)。 (6)新冠病毒感染后出现严重乏力、咳嗽、胸闷、心悸、腹痛、恶心、头晕等新冠并发症或后遗症,需药物治疗干预者。 (7)一个月内参加过其他临床试验者。

Exclusion criteria:

(1) Those with severe diseases such as heart, liver, kidney, immune system, and hematopoietic system. (2) Individuals with a history of severe emotional disorders or mental illness or a family history of mental illness; (3) Pregnant or lactating women. (4) Due to allergies and other reasons, patients cannot be treated with traditional Chinese medicine prescriptions. (5) Patients with acute COVID-19 infection (re infected with COVID-19 within 2 weeks). (6) After COVID-19 infection, severe fatigue, cough, chest tightness, palpitations, abdominal pain, nausea, dizziness and other COVID-19 complications or sequelae occur, and drug treatment intervention is required. (7) Participated in other clinical trials within one month.

研究实施时间:

Study execute time:

From 2023-07-21

To      2025-07-21

征募观察对象时间:

Recruiting time:

From 2023-07-26

To      2025-07-21

干预措施:

Interventions:

组别:

治疗组

样本量:

30

Group:

Treatment group

Sample size:

干预措施:

桑术养正饮口服给予治疗14天,以开水泡服,每次200ml,每天泡3遍,共600ml。

干预措施代码:

Intervention:

Sangzhu Yangzheng Decoction was given orally for 14 days, soaked in boiled water, 200ml each time, soaked 3 times a day, a total of 600 ml

Intervention code:

组别:

对照组

样本量:

30

Group:

control group

Sample size:

干预措施:

干预措施代码:

Intervention:

Nil

Intervention code:

样本总量 Total sample size : 60

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

北京

市(区县):

延庆区

Country:

China

Province:

Beijing

City:

单位(医院):

北京中医医院延庆医院

单位级别:

二级甲等

Institution/hospital:

Yanqing hospital, Beijing traditional Chinese medicine hospital

Level of the institution:

Secondary A

测量指标:

Outcomes:

指标中文名:

TBNK淋巴细胞亚群分析

指标类型:

主要指标

Outcome:

Analysis of TBNK lymphocyte subpopulations

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

免疫球蛋白A

指标类型:

次要指标

Outcome:

IgA

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

免疫球蛋白G

指标类型:

次要指标

Outcome:

IgG

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

新型冠状病毒lgM抗体

指标类型:

次要指标

Outcome:

IgM antibody to novel coronavirus

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

新型冠状病毒lgG抗体

指标类型:

次要指标

Outcome:

IgG antibody to novel coronavirus

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

上呼吸道菌群

指标类型:

次要指标

Outcome:

Upper respiratory tract flora

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

免疫球蛋白M

指标类型:

次要指标

Outcome:

IgM

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Treg及Th1/Th2/Th17检测

指标类型:

主要指标

Outcome:

Detection of Treg and Th1, Th2 and Th17

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:

血液

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:

咽拭子

组织:

Sample Name:

Throat swab

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 18
Min age years
最大 65
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):

本研究采用计算机生成随机数字表,按随机数字表,将对应的分组代码装入信封并密封(拆封后不可复原)。按顺序号依次纳入受试者,依据信封内的分组代码,将受试者随机分配到试验组和对照组。由不参与本研究的一名人员采用电话方式分配随机号。

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

This study used a computer-generated random number table, According to the random number table, the corresponding grouping code was put into an envelope and sealed (it cannot be recovered after open).Include the subjects in sequence by number, and randomly assign them to the experimental group and control group based on the grouping code inside the envelope. A random number was assigned by a person who was not involved in this study over the phone.

盲法:

Blinding:

None

是否共享原始数据:

IPD sharing:

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):

发表文章

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

By publishing articles

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:

CRF

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

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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