复方银花解毒颗粒治疗新型冠状病毒感染的有效性与安全性临床随机对照研究

注册号:

Registration number:

ITMCTR2200006859

最近更新日期:

Date of Last Refreshed on:

2022-12-12

注册时间:

Date of Registration:

2022-12-12

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

复方银花解毒颗粒治疗新型冠状病毒感染的有效性与安全性临床随机对照研究

Public title:

A randomized controlled study to evaluate the efficacy and safety of Fufang Yinhua detoxification granules in COVID-19 infection

注册题目简写:

English Acronym:

研究课题的正式科学名称:

复方银花解毒颗粒治疗新型冠状病毒感染的有效性与安全性临床随机对照研究

Scientific title:

A randomized controlled study to evaluate the efficacy and safety of Fufang Yinhua detoxification granules in COVID-19 infection

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:

ChiCTR2200066613 ; ChiMCTR2200006859

申请注册联系人:

陈翔

研究负责人:

周光明

Applicant:

Xiang Chen

Study leader:

Guangming Zhou

申请注册联系人电话:

Applicant telephone:

13861535066

研究负责人电话:

Study leader's telephone:

13901530099

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:

staff984@yxph.com

研究负责人电子邮件:

Study leader's E-mail:

staff349@yxph.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:

江苏省无锡市宜兴市通贞观路75号

研究负责人通讯地址:

江苏省无锡市宜兴市通贞观路75号

Applicant address:

75 Tongzhenguan Road, Yixing City, Wuxi City, Jiangsu Province

Study leader's address:

75 Tongzhenguan Road, Yixing City, Wuxi City, Jiangsu Province

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:

宜兴市人民医院

Applicant's institution:

Yixing People's 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:

伦审2022科172-01

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:

宜兴市人民医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Yixing People's Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2022/12/10 0:00:00

伦理委员会联系人:

Contact Name of the ethic committee:

伦理委员会联系地址:

Contact Address of the ethic committee:

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:

宜兴市人民医院

Primary sponsor:

Yixing People's Hospital

研究实施负责(组长)单位地址:

江苏省无锡市宜兴市通贞观路75号

Primary sponsor's address:

75 Tongzhenguan Road, Yixing City, Wuxi City, Jiangsu Province

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

市(区县):

宜兴

Country:

China

Province:

Jiangsu

City:

Yixing

单位(医院):

宜兴市人民医院

具体地址:

江苏省无锡市宜兴市通贞观路75号

Institution
hospital:

Yixing People's Hospital

Address:

75 Tongzhenguan Road, Yixing City, Wuxi City, Jiangsu Province

经费或物资来源:

企业资助

Source(s) of funding:

corporate funding

研究疾病:

新型冠状病毒肺炎

研究疾病代码:

Target disease:

COVID-19

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:

上市后药物

Post-marketing clinical trial

研究目的:

评价复方银花解毒颗粒治疗新型冠状病毒感染的有效性和安全性。

Objectives of Study:

To evaluate the efficacy and safety of Fufang Yinhua detoxification granules in the treatment of novel coronavirus 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:

1)感染者的临床分型依据国家卫生健康委员会制定的《新型冠状病毒肺炎诊疗方案(试行第九版)》确定; 2)SARS-CoV-2核酸检测阳性; 3)年龄≥18周岁; 4)有临床症状(发热、咳嗽、咽痛、乏力等)的感染者或者血项检查有异常; 5)受试者充分理解、自愿参加临床试验,并签署书面知情同意书。

Inclusion criteria

1) Clinically diagnosed with COVID-19 classificated according to the Diagnosis and Treatment Protocol for COVID-19 (Trial Version 9 formulated by the National Health Commission; 2) SARS-CoV-2 nucleic acid test is positive; 3) Age ≥18 years old; 4) Infected subjects with clinical symptoms (fever, cough, sore throat, fatigue, etc.) or abnormal of hematology; 5) Subjects fully understand and participate this trial voluntarily, and sign Informed Consent Form.

排除标准:

1)筛选检查前5天内使用过具有抗新型冠状病毒的药理作用或临床作用的药物或含有与试验药物类似成分中药的患者,包括但不限于金花清感、连花清瘟、板蓝根、Paxlovid、阿兹夫定等; 2)筛选检查前28天内或正在接受COVID-19单克隆抗体、恢复期血浆,或正在使用其他禁用的合并用药的患者; 3)筛选检查前28天内曾接种SARS-CoV-2疫苗的患者或计划于访视期和随访期期间接种SARS-CoV-2疫苗的患者; 4)免疫缺陷患者(如:恶性肿瘤患者、器官或骨髓移植者、艾滋病患者、长期使用皮质类固醇或其他免疫抑制药物导致免疫功能减退状态); 5)有严重的心脑血管疾病、慢性肺部疾病(慢性阻塞性肺疾病、中度至重度哮喘、间质性肺疾病)、控制不良的糖尿病、肿瘤等基础疾病者; 6)已知对研究用药所含成分过敏者,或过敏体质患者; 7)任何影响药物吸收的胃肠道疾病史(包括但不限于反流性食管炎、慢性腹泻、炎症性肠病、肠结核、胃泌素瘤、短肠综合征、胃大部切除术后等); 8)处于哺乳期、妊娠期的妇女; 9)怀疑或确有酒精、药物滥用史或精神疾病史者; 10)筛选检查前1个月内参加过其他药物临床试验的患者; 11)研究者认为不适宜参加本研究的其他患者。

Exclusion criteria:

1) Subjects who have used drugs with pharmacological or clinical effects against novel coronavirus or traditional Chinese medicine containing similar ingredients to the study drug within 5 days prior to screening, including but not limited to Jinhua Qinggan, Lianhua Qingwen, Radix isatidis, Paxlovid, Azifudine, etc.; 2) Subjects receiving COVID-19 monoclonal antibodies, convalescent plasma, or other concomitant drugs within 28 days prior to screening; 3) Subjects who had SARS-CoV-2 vaccination within 28 days prior to screening or who planned to vaccinateSARS-CoV-2 during the visit and follow-up period; 4) Immunodeficient subjects (such as patients with malignant tumors, organ or bone marrow transplants, AIDS patients, long-term use of corticosteroids or other immunosuppressive drugs resulting in immune dysfunction); 5) Subjects with serious cardiovascular and cerebrovascular diseases, chronic pulmonary diseases (chronic obstructive pulmonary disease, moderate to severe asthma, interstitial pulmonary disease), inadequately controlleddiabetes, tumor and other underlying diseases; 6) Subjects who are allergic to the ingredients contained in the study drug, or subjects are in allergic constitution; 7) Medicalhistory of gastrointestinal diseases that affect drug absorption (including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, post-subtotal gastrectomy, etc.); 8) Women in the lactation or pregnancy period; 9) Suspected or confirmed history of alcohol, drug abuse or mental illness; 10) Subjects who participated in other clinical trials of drugs within 1 month before screening; 11) Any other factor that the investigator considered unsuitable for participation.

研究实施时间:

Study execute time:

From 2022-12-10

To      2022-12-31

征募观察对象时间:

Recruiting time:

From 2022-12-12

To      2022-12-30

干预措施:

Interventions:

组别:

试验组

样本量:

100

Group:

trial arm

Sample size:

干预措施:

复方银花解毒颗粒

干预措施代码:

Intervention:

Fufang Yinhua detoxification granules

Intervention code:

组别:

对照组

样本量:

100

Group:

control arm

Sample size:

干预措施:

连花清瘟颗粒

干预措施代码:

Intervention:

Lianhua Qingwen granules

Intervention code:

样本总量 Total sample size : 200

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):

宜兴

Country:

China

Province:

Jiangsu

City:

Yixing

单位(医院):

宜兴市人民医院

单位级别:

三级甲等

Institution/hospital:

Yixing People's Hospital

Level of the institution:

tertiary hospital

测量指标:

Outcomes:

指标中文名:

给药前后血常规变化情况

指标类型:

次要指标

Outcome:

Changes of blood routine before and after administration

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

进展为普通型、重型或危重型COVID-19的受试者比例

指标类型:

次要指标

Outcome:

Proportion of subjects who progressed to normal, severe or critical COVID-19

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

首次给药至各临床症状(如发热、咳嗽、咽痛、乏力等)恢复的时间

指标类型:

主要指标

Outcome:

Time between initial administration and recovery of clinical symptoms (e.g. fever, cough, sore throat, fatigue, etc.)

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

首次给药至首次核酸转阴的时间

指标类型:

次要指标

Outcome:

Time between initial administration and nucleic acid turning negative for the first time

Type:

Secondary 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:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大
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):

统计学专家用计算机生成的随机数用来生成随机序列,将参与者分配给试验组或对照组。药物序列将根据随机化列表随机分配给受试者,每个受试者根据随机表给药。

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

Subjects are assigned to a treatment group or a control group according to random sequence, which is computer-generated by Statistician. Each subject will be administered according to the drug sequences ,which are based on a randomized list.

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

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):

研究数据以论文形式将在2023发表

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

The paper will be published in 2023

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:

采用CRF采集数据。研究者准确、及时、完整、规范的记录数据;数据录入后不得随意更改。

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

CRF was used to collect data. Researchers accurately, timely, complete and standardized record data; Data shall not be changed after input.

数据管理委员会:

Data Managemen Committee:

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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