流感的综合防治方案研究

注册号:

Registration number:

ITMCTR2024000109

最近更新日期:

Date of Last Refreshed on:

2024-06-24

注册时间:

Date of Registration:

2024-06-24

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

流感的综合防治方案研究

Public title:

Research on integrated control protocols for influenza

注册题目简写:

English Acronym:

研究课题的正式科学名称:

感染性疾病的中医药综合防治研究

Scientific title:

Research on Integrated Prevention and Treatment of Infectious Diseases with Traditional Chinese Medicine

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:

汪九重

研究负责人:

吕文良

Applicant:

Jiuchong Wang

Study leader:

Wenliang Lv

申请注册联系人电话:

Applicant telephone:

15911136239

研究负责人电话:

Study leader's telephone:

18601237779

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:

15911136239@126.com

研究负责人电子邮件:

Study leader's E-mail:

lvwenliang@sohu.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:

北京市西城区北线阁街5号 

研究负责人通讯地址:

北京市西城区北线阁街5号 

Applicant address:

No.5 Beixiange Xicheng District, Beijing

Study leader's address:

No.5 Beixi Xicheng District, Beijing

申请注册联系人邮政编码:

Applicant postcode:

100053

研究负责人邮政编码:

Study leader's postcode:

100053

申请人所在单位:

中国中医科学院广安门医院

Applicant's institution:

Guang'anmen 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:

2024-020-KY

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:

中国中医科学院广安门医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee, Guang'anmen Hospital, China Academy of Traditional Chinese Medicine, China

伦理委员会批准日期:

Date of approved by ethic committee:

2024/2/2 0:00:00

伦理委员会联系人:

乔洁

Contact Name of the ethic committee:

Jie Qiao

伦理委员会联系地址:

北京市西城区北线阁街5号 

Contact Address of the ethic committee:

No.5 Beixiange Xicheng District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-88001552

伦理委员会联系人邮箱:

Contact email of the ethic committee:

gamhec@126.com

研究实施负责(组长)单位:

中国中医科学院广安门医院

Primary sponsor:

Guang'anmen Hospital

研究实施负责(组长)单位地址:

北京市西城区北线阁街5号 

Primary sponsor's address:

No.5 Beixi Xicheng 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):

Beijing

Country:

China

Province:

Beijing

City:

Beijing

单位(医院):

中国中医科学院广安门医院

具体地址:

北京市西城区北线阁街5号 

Institution
hospital:

Guang'anmen Hospital

Address:

No.5 Beixi Xicheng District, Beijing

经费或物资来源:

中央高水平中医医院临床研究和成果转化能力提升项目-中医药临床循证研究专项

Source(s) of funding:

Central High-level Chinese Medicine Hospital Clinical Research and Achievement Translation Capacity Enhancement Project - Special Programme for Clinical Evidence-based Research in Chinese Medicine

研究疾病:

甲型流行性感冒

研究疾病代码:

J10.001

Target disease:

Influenza A

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机交叉对照

randomized controlled trial(cross-over design)

研究所处阶段:

Study phase:

I期临床试验

Phase I clinical trial

研究目的:

本项目拟通过随机对照研究,客观评价及验证黄芪九味败毒汤联合磷酸奥司他韦治疗表寒里热证甲型流感患者的有效性及安全性。

Objectives of Study:

This project intends to objectively evaluate and validate the efficacy and safety of Astragalus and Nine Materia Medica Severe Toxin Soup combined with oseltamivir phosphate in the treatment of patients with influenza A with surface cold and internal heat by means of a randomised controlled study.

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)符合甲型流感西医诊断; 2)符合表寒里热证中医辨证标准; 3)年龄在 18-70 岁之间,性别不限; 4)发病时间≤48h; 5)体温≥37.3℃; 6)愿意参加本课题研究并签署知情同意书

Inclusion criteria

(1) Compliance with western medical diagnosis of influenza A; (2) Comply with the Chinese medicine diagnostic criteria for the syndrome of surface cold and internal heat; (3) Age between 18-70 years old, gender is not limited; 4) Onset time ≤ 48h; (5) Body temperature ≥37.3℃; (6) Willing to participate in the study and sign an informed consent form.

排除标准:

1)重症流感、危重症流感、流感病毒性肺炎患者; 2)合并有细菌、真菌或其他呼吸道病毒(如呼吸道合胞病毒、鼻病毒等)感染 患者; 3)合并肺、心、脑、肝、肾等系统原发性疾病患者; 4)妊娠或哺乳期妇女以及计划在研究期内妊娠的妇女; 5)已知对研究产品的组成成分过敏,或过敏体质者; 6)有精神异常不能配合本研究的患者,或病情不稳定的癫痫病患者; 7)就诊前已使用抗病毒的药物治疗者; 8)有其他不宜做药物试验观察者,或不能配合治疗,难以对药物的有效性和安 全性作出确切评价者。

Exclusion criteria:

1) Patients with severe influenza, critically ill influenza, or influenza viral pneumonia; 2) Combined bacterial, fungal, or other respiratory viral (e.g., respiratory syncytial virus, rhinovirus, etc.) infection Patients; (3) Patients with combined serious primary diseases of the lung, heart, brain, liver, kidney and other systems; (4) Pregnant or breastfeeding women and women who plan to become pregnant during the study period; (5) Known allergy to the components of the research product, or allergy; 6) Patients with psychiatric abnormalities who cannot cooperate with the study, or patients with epilepsy with unstable conditions; 7) Those who have been treated with anti-viral medications prior to the visit; (8) Those who have other inappropriate drug test observation, or cannot cooperate with the treatment, and it is difficult to make a definitive evaluation of the effectiveness and safety of the drug. The patients who are not able to cooperate with the treatment, and it is difficult to make a definite evaluation of the effectiveness and safety of the drugs.

研究实施时间:

Study execute time:

From 2024-07-01

To      2026-11-30

征募观察对象时间:

Recruiting time:

From 2024-07-01

To      2026-11-30

干预措施:

Interventions:

组别:

中药组

样本量:

100

Group:

Chinese Medicines Group

Sample size:

干预措施:

予黄芪九味败毒汤口服治疗

干预措施代码:

Intervention:

Oral treatment with Huangqi Jiuwei Baidu Decoction

Intervention code:

组别:

西药组

样本量:

100

Group:

Western medicine group

Sample size:

干预措施:

予磷酸奥司他韦胶囊

干预措施代码:

Intervention:

Ignore oseltamivir phosphate capsules

Intervention code:

组别:

中药+西药组

样本量:

100

Group:

Chinese medicine combined with western medicine group

Sample size:

干预措施:

黄芪九味败毒汤联合磷酸奥司他韦胶囊治疗

干预措施代码:

Intervention:

Astragalus and Huangqi Jiuwei Baidu decoction combined with oseltamivir phosphate capsule for the treatment of

Intervention code:

样本总量 Total sample size : 300

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

省/直辖市

市(区县):

Beijing

Country:

China

Province:

省/直辖市

City:

Beijing

单位(医院):

中国中医科学院广安门医院

单位级别:

三甲

Institution/hospital:

Guang'anmen Hospital

Level of the institution:

Tertiary hospital

测量指标:

Outcomes:

指标中文名:

中医证候积分

指标类型:

次要指标

Outcome:

Chinese Medicine Score

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗前和治疗后舌象

指标类型:

次要指标

Outcome:

Pre- and post-treatment tongue image

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清学指标

指标类型:

次要指标

Outcome:

Serological indicators

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗原转阴时间/率

指标类型:

主要指标

Outcome:

Antigen conversion time/rate

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:

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 70
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):

通过R语言软件生成随机数字并产生随机分配结果,患者按照 1:1:1 的比例随机分组

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

Random numbers are generated by R language software and random allocation results are produced, with patients randomly grouped in a 1:1:1 ratio

盲法:

Blinding:

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):

暂不共享

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

unshared

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(Case Record Form, CRF)

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:

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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