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A real-world study for the Chinese medicines ''Xinguan 2'' and ''Xinguan 3'' in the treatment of novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000030936 

最近更新日期:

Date of Last Refreshed on:

2020-03-23 

注册时间:

Date of Registration:

2020-03-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

请尽快上传伦理审批文件。 成都中医药大学附属医院联合开展医院制剂“银翘藿朴退热合剂(新冠2号)、荆防藿朴解毒合剂(新冠3号)”治疗新型冠状病毒肺炎(COVID-19)临床疗效评价的真实世界研究 

Public title:

A real-world study for the Chinese medicines ''Xinguan 2'' and ''Xinguan 3'' in the treatment of novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

成都中医药大学附属医院联合开展医院制剂“银翘藿朴退热合剂(新冠2号)、荆防藿朴解毒合剂(新冠3号)”临床疗效评价的真实世界研究 

Scientific title:

Hospital of Chengdu University of Traditional Chinese Medicine jointly launched a real-world study on the clinical efficacy evaluation of the Inner hospital preparation  

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:

ChiMCTR2000003149 

申请注册联系人:

孔晓岚 

研究负责人:

高培阳 

Applicant:

Xiaolan Kong 

Study leader:

Peiyang Gao 

申请注册联系人电话:

Applicant telephone:

+86 13693438696 

研究负责人电话:

Study leader's telephone:

+86 18980025566 

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:

394731278@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

gaopy930@126.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:

成都市金牛区十二桥路39号 

研究负责人通讯地址:

成都市金牛区十二桥路39号 

Applicant address:

39 Shi-er-qiao Road, Chengdu, Sichua, China 

Study leader's address:

39 Shi-er-qiao Road, Chengdu, Sichua, China 

申请注册联系人邮政编码:

Applicant postcode:

610072 

研究负责人邮政编码:

Study leader's postcode:

610072 

申请人所在单位:

成都中医药大学附属医院 

Applicant's institution:

Hospital of Chengdu University of Traditional Chinese Medicine 

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:

2020QKL-009 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

四川中医药区域伦理审查委员会 

Name of the ethic committee:

Sichuan Traditional Chinese Medicine Regional Ethics Review Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-03-09 

伦理委员会联系人:

何清 

Contact Name of the ethic committee:

Qing He 

伦理委员会联系地址:

四川省成都市成都中医药大学附属医院伦理审查办公室 

Contact Address of the ethic committee:

Ethics Review Office, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, 39 Shi-er-qiao Road, Chengdu, Sichua, China 

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:

成都中医药大学附属医院 

Primary sponsor:

Hospital of Chengdu University of Traditional Chinese Medicine. 

研究实施负责(组长)单位地址:

成都市金牛区十二桥路39号 

Primary sponsor's address:

39 Shi-er-qiao Road, Chengdu, Sichua, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

四川

市(区县):

成都市

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

成都中医药大学附属医院

具体地址:

成都市金牛区十二桥路39号

Institution
hospital:

Hospital of Chengdu University of Traditional Chinese Medicine.

Address:

39 Shi-er-qiao Road

经费或物资来源:

自筹 

Source(s) of funding:

Self-financing 

研究疾病:

新型冠状病毒肺炎(COVID-19) 

Target disease:

Novel Coronavirus Pneumonia (COVID-19) 

研究疾病代码:

 

Target disease code:

 

研究类型:

治疗研究 

Study type:

Treatment study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

评价医院制剂“银翘藿朴退热合剂(新冠2号)”、“荆防藿朴解毒合剂(新冠3号)”治疗新型冠状病毒肺炎临床疗效和安全性。 

Objectives of Study:

Evaluate the clinical efficacy and safety of the hospital preparations "Yinqiaohuopu Tuire Mixture (Xinguan No. 2)" and "Jingfanghuopujiedu Mixture (Xinguan No. 3)" in the treatment of new coronavirus pneumonia. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

半随机对照 

Study design:

Quasi-randomized controlled 

纳入标准:

1)新型冠状病毒肺炎疫情期间,由呼吸道感染引起的发热患者(体温>37℃),无论是否为新冠肺炎疑似或确诊病例; 2)符合中医风热夹湿证或风寒夹湿证的诊断标准; 3)18岁≤年龄≤75岁; 4)二级及以上医疗机构接诊的门诊或住院患者; 5)自愿加入本研究,依从性好,签署知情同意书。 

Inclusion criteria

1. During the outbreak of new coronavirus pneumonia, patients with fever caused by respiratory infection (body temperature > 37 degree C), whether or not they are suspected or confirmed cases of new coronary pneumonia; 2. Comply with the diagnostic criteria of TCM for wind-heat and dampness or wind-cold and dampness syndrome; 3. Aged 18 to 75 years; 4. Outpatients or inpatients admitted by second-level and above medical institutions; 5. Voluntarily joined the study, with good compliance and signed informed consent. 

排除标准:

1)已知对本研究药物组成成份过敏; 2)无发热的非新冠肺炎确诊或疑似患者; 3)其他非感染性病因引起的发热患者; 4)合并有肺结核、支气管哮喘、慢性阻塞性肺疾病、呼吸衰竭的患者; 5)不愿意服用中药制剂的患者; 6)妊娠期及哺乳期妇女、近3个月有生育要求者; 7)正在参加其他药物临床试验; 8)其他原因导致研究者认为不适合参加本研究。 

Exclusion criteria:

1. Known allergies to the components of this study; 2. Non-fever non-new coronary pneumonia diagnosed or suspected; 3. Fever caused by other non-infectious causes; 4. Patients with tuberculosis, bronchial asthma, chronic obstructive pulmonary disease, and respiratory failure; 5. Patients who are unwilling to take traditional Chinese medicine preparations; 6. Women during pregnancy and lactation who have fertility requirements in the last 3 months; 7. Participating in clinical trials of other drugs; 8. Other reasons led the researchers to consider it inappropriate to participate in this study. 

研究实施时间:

Study execute time:

From2020-03-10To 2020-05-10 

干预措施:

Interventions:

组别:

治疗组

样本量:

2130

Group:

CM group

Sample size:

干预措施:

新冠2号/新冠3号单用或+常规治疗

干预措施代码:

Intervention:

Xinguan No. 2 / Xinguan No. 3 alone or + regular treatment

Intervention code:

组别:

对照组

样本量:

710

Group:

WM group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

Regular Ttreatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

德阳 

Country:

China 

Province:

Sichuan 

City:

Deyang 

单位(医院):

德阳市中西医结合医院 

单位级别:

二甲医院 

Institution
hospital:

Deyang City Hospital of Integrated Traditional Chinese and Western Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

广元 

Country:

China 

Province:

Sichuan 

City:

Guangyuan 

单位(医院):

广元市中医医院 

单位级别:

三甲医院 

Institution
hospital:

Guangyuan Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

攀枝花市 

Country:

China 

Province:

Sichuan 

City:

Panzhihua 

单位(医院):

攀枝花学院附属医院/攀枝花市中西医结合医院 

单位级别:

三甲医院 

Institution
hospital:

Affiliated Hospital of Panzhihua University / Panzhihua City Integrated Traditional Chinese and Western Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

雅安 

Country:

China 

Province:

Sichuan 

City:

Yaan 

单位(医院):

雅安市中医医院 

单位级别:

三甲医院 

Institution
hospital:

Ya'an Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

自贡 

Country:

China 

Province:

Sichuan 

City:

Zigong 

单位(医院):

自贡市第一人民医院 

单位级别:

三甲医院 

Institution
hospital:

Zigong First People's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

自贡 

Country:

China 

Province:

Sichuan 

City:

Zigong 

单位(医院):

自贡市中医医院 

单位级别:

三甲医院 

Institution
hospital:

Zigong Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

成都中医药大学附属医院 

单位级别:

三甲医院 

Institution
hospital:

Hospital of Chengdu University of Traditional Chinese Medicine.  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川省中西医结合医院 

单位级别:

三甲医院 

Institution
hospital:

Sichuan Provincial Hospital of Integrated Traditional Chinese and Western Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

内江市中医医院 

单位级别:

三甲医院 

Institution
hospital:

Neijiang Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

内江市第二人民医院 

单位级别:

三甲医院 

Institution
hospital:

Neijiang Second People's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

西南医科大学附属中医医院 

单位级别:

三甲医院 

Institution
hospital:

Traditional Chinese Medicine Hospital of Southwest Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

绵阳市中医医院 

单位级别:

三甲医院 

Institution
hospital:

Mianyang Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

南充市中心医院 

单位级别:

三甲医院 

Institution
hospital:

Nanchong Central Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

广安市人民医院 

单位级别:

三甲医院 

Institution
hospital:

Guang'an People's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

成都市第五人民医院 

单位级别:

三甲医院 

Institution
hospital:

Chengdu Fifth People's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

成都医学院第一附属医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital of Chengdu Medical College  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

阿坝州人民医院 

单位级别:

三甲医院 

Institution
hospital:

Aba People's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

资阳市中医医院 

单位级别:

三乙医院 

Institution
hospital:

Ziyang Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

巴中市中医院 

单位级别:

三甲医院 

Institution
hospital:

Bazhong Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

乐山市中医医院 

单位级别:

三甲医院 

Institution
hospital:

Leshan Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

什邡市中医院 

单位级别:

二甲医院 

Institution
hospital:

Shifang Traditional Chinese Medicine Hospital  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

罗江区中医院 

单位级别:

二甲医院 

Institution
hospital:

Luojiang District Traditional Chinese Medicine Hospital  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

广元市第三人民医院 

单位级别:

三乙医院 

Institution
hospital:

Guangyuan Third People's Hospital  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

苍溪县中医医院 

单位级别:

三甲医院 

Institution
hospital:

Cangxi County Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

广元市利州区中医医院 

单位级别:

二甲医院 

Institution
hospital:

Guangzhou Lizhou District Traditional Chinese Medicine Hospital  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

攀枝花市第四人民医院 

单位级别:

二甲医院 

Institution
hospital:

The Fourth People's Hospital of Panzhihua  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

攀枝花市十九冶医院 

单位级别:

二甲医院 

Institution
hospital:

No.19 Metallurgical Hospital of Panzhihua  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

汉源县中医医院 

单位级别:

二甲医院 

Institution
hospital:

Hanyuan County Traditional Chinese Medicine Hospital  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

雅安市人民医院 

单位级别:

三甲医院 

Institution
hospital:

Ya'an People's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

自贡市妇幼保健院 

单位级别:

三甲医院 

Institution
hospital:

Zigong Maternal and Child Health Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

自贡市自流井区中医院 

单位级别:

二甲医院 

Institution
hospital:

Chinese Medicine Hospital of Ziliujing District, Zigong City  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

荣县中医医院 

单位级别:

二甲医院 

Institution
hospital:

Rongxian Traditional Chinese Medicine Hospital  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

富顺县人民医院 

单位级别:

二甲医院 

Institution
hospital:

Fushun County People's Hospital  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

射洪市中医医院 

单位级别:

三甲医院 

Institution
hospital:

Shehong Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

彭州市中西医结合医 

单位级别:

二乙医院 

Institution
hospital:

Pengzhou Integrated Traditional Chinese and Western Medicine Hospital  

Level of the institution:

Secondary B Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

内江市隆昌市中医医院 

单位级别:

三乙医院 

Institution
hospital:

Neijiang Longchang Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

内江市东兴区人民医院 

单位级别:

三乙医院 

Institution
hospital:

Neijiang Dongxing District People's Hospital  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

资中县人民医院 

单位级别:

三乙医院 

Institution
hospital:

Zizhong County People's Hospital  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

隆昌市人民医院 

单位级别:

三乙医院 

Institution
hospital:

Longchang People's Hospital  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

威远县人民医院 

单位级别:

三乙医院 

Institution
hospital:

Weiyuan County People's Hospital  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

合江县中医医院 

单位级别:

三乙医院 

Institution
hospital:

Hejiang County Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

叙永县中医医院 

单位级别:

三乙医院 

Institution
hospital:

Xuyong County Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

富顺县中医医院 

单位级别:

三乙医院 

Institution
hospital:

Fushun County Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

三台县中医医院 

单位级别:

三甲医院 

Institution
hospital:

Santai County Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

梓潼中医院 

单位级别:

二甲医院 

Institution
hospital:

Zitong County Traditional Chinese Medicine Hospital  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

北川县中医医院 

单位级别:

二乙医院 

Institution
hospital:

Beichuan County Traditional Chinese Medicine Hospital  

Level of the institution:

Secondary B Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

川北医学院附属医院 

单位级别:

三甲医院 

Institution
hospital:

Affiliated Hospital of North Sichuan Medical College  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

南充市中医院 

单位级别:

三甲医院 

Institution
hospital:

Nanchong Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

华蓥市人民医院 

单位级别:

二甲医院 

Institution
hospital:

Huaying People's Hospital  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

武胜县人民医院 

单位级别:

二甲医院 

Institution
hospital:

Wusheng County People's Hospital  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

岳池县人民医院 

单位级别:

三乙医院 

Institution
hospital:

Yuechi County People's Hospital  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

邻水县人民医院 

单位级别:

三乙医院 

Institution
hospital:

Linshui County People's Hospital  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川省革命伤残军人医院 

单位级别:

二乙医院 

Institution
hospital:

Revolutionary Disabled Military Hospital of Sichuan Province  

Level of the institution:

Secondary B Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

彭州市第二人民医院 

单位级别:

二乙医院 

Institution
hospital:

Second People's Hospital of Pengzhou  

Level of the institution:

Secondary B Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

雅安市名山区人民医院 

单位级别:

二甲医院 

Institution
hospital:

Ya'an Mingshan People's Hospital  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

郫都区人民医院 

单位级别:

三乙医院 

Institution
hospital:

Pidu District People's Hospital  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

温江区人民医院 

单位级别:

三乙医院 

Institution
hospital:

People's Hospital of Wenjiang District  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

双流县中医医院 

单位级别:

三乙医院 

Institution
hospital:

Shuangliu County Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

郫都区中医医院 

单位级别:

三乙医院 

Institution
hospital:

Pidu District Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

道孚县人民医院 

单位级别:

二乙医院 

Institution
hospital:

Daofu County People's Hospital  

Level of the institution:

Secondary B Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

金堂县中医医院 

单位级别:

二甲医院 

Institution
hospital:

Jintang County Traditional Chinese Medicine Hospital  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

青白江区中医医院 

单位级别:

二甲医院 

Institution
hospital:

Qingbaijiang District Traditional Chinese Medicine Hospital  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

温江区中医医院 

单位级别:

二甲医院 

Institution
hospital:

Wenjiang District Traditional Chinese Medicine Hospital  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

马尔康市人民医院 

单位级别:

二乙医院 

Institution
hospital:

People's Hospital of Maerkang  

Level of the institution:

Secondary B Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

茂县人民医院 

单位级别:

二甲医院 

Institution
hospital:

Maoxian People's Hospital  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

安岳县中医医院 

单位级别:

三甲医院 

Institution
hospital:

Anyue County Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

乐至县中医医院 

单位级别:

二甲医院 

Institution
hospital:

Lezhi County Traditional Chinese Medicine Hospital  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

巴中市平昌县中医医院 

单位级别:

二甲医院 

Institution
hospital:

Pingchang County Traditional Chinese Medicine Hospital of Bazhong City  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

巴中市南江县中医医院 

单位级别:

三乙医院 

Institution
hospital:

Nanjiang County Traditional Chinese Medicine Hospital,Bazhong City  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

五通桥区中医医院 

单位级别:

二甲医院 

Institution
hospital:

Wutongqiao District Traditional Chinese Medicine Hospital  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

峨眉山市中医医院 

单位级别:

三乙医院 

Institution
hospital:

Emeishan Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary B Hospital 

测量指标:

Outcomes:

指标中文名:

体温恢复正常时间

指标类型:

主要指标 

Outcome:

Body temperature returns to normal time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

用药结束后,中医症状消失率

指标类型:

主要指标 

Outcome:

After the medication, the disappearance rate of TCM symptoms

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:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 75 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):

本研究采用静态区组随机方法,中心以及分层分配入组, 采用CIMS随机系统进行随机。符合入排标准的受试者, 按照中医辨证证型(风热/风寒)进行分层。 采用中心下分层中每 N 个受试者编号为 1 个区组。受试者编号格式为□□□□, 为 4 位数字,表示受试者随机号,如 0001。

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

In this study, a static block randomization method was used. Subjects who met the inclusion criteria were stratified according to TCM syndrome type (wind heat / wind cold). Each N subjects in the subcenter stratum were numbered as 1 block. The subject number format is □□□□, which is a 4-d

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

论文支持材料

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

surpporting materials for the artical.

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:

Case Record Form

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-03-18
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