注册号: Registration number: |
ChiCTR2000031944 |
最近更新日期: Date of Last Refreshed on: |
2020-04-15 |
注册时间: Date of Registration: |
2020-04-15 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
中药茶饮预防新型冠状病毒肺炎(COVID-19)的作用:随机对照试验 |
Public title: |
Efficacy of Chinese Herbal Tea in the Prevention of Novel Coronavirus Pneumonia (COVID-19): a Randomized Controlled Trial |
注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
武汉市复工人群服用中药茶饮预防新型冠状病毒肺炎(COVID-19)的研究:随机对照试验 |
Scientific title: |
Efficacy of Chinese Herbal Tea in the Prevention of Novel Coronavirus Pneumonia (COVID-19) for Returning Workers in Wuhan: a Randomized Controlled Trial |
研究课题代号(代码): Study subject ID: |
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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: |
ChiMCTR2000003212 |
申请注册联系人: |
刘斌 |
研究负责人: |
吕诚 |
Applicant: |
Liu Bin |
Study leader: |
Lu Cheng |
申请注册联系人电话: Applicant telephone: |
+86 010-64093104 |
研究负责人电话: Study leader's telephone: |
+86 010-64093264 |
申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
lynch1123@126.com |
研究负责人电子邮件: Study leader's E-mail: |
lv_cheng0816@163.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): |
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申请注册联系人通讯地址: |
北京市东城区东直门内南小街16号 |
研究负责人通讯地址: |
北京市东城区东直门内南小街16号 |
Applicant address: |
16 Nanxiao Street, Dongzhimennei, Dongcheng District, Beijing, China |
Study leader's address: |
16 Nanxiao Street, Dongzhimennei, 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: |
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申请人所在单位: |
中国中医科学院 |
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Applicant's institution: |
China Academy of Chinese Medical Sciences |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
CACMS-IRB2020-004 |
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: |
中国中医科学院医学伦理委员会 |
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Name of the ethic committee: |
Ethics Review Committee of China Academy of Chinese Medical Sciences |
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伦理委员会批准日期: Date of approved by ethic committee: |
2020-04-14 | ||
伦理委员会联系人: |
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Contact Name of the ethic committee: |
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伦理委员会联系地址: |
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Contact Address of the ethic committee: |
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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: |
中国中医科学院 |
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Primary sponsor: |
China Academy of Chinese Medical Sciences |
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研究实施负责(组长)单位地址: |
北京市东城区东直门内南小街16号 |
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Primary sponsor's address: |
16 Nanxiao Street, Dongzhimennei, Dongcheng District, Beijing, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
国家重点研发计划资助(No.2020YFC0841500) |
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Source(s) of funding: |
National Key R&D Program of China (No.2020YFC0841500) |
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研究疾病: |
新型冠状病毒肺炎 |
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Target disease: |
Novel Coronavirus Pneumonia (COVID-19) |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
Study phase: |
N/A |
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研究目的: |
评价中药茶饮对武汉市复工人群预防新型冠状病毒肺炎(COVID-19)的效果。 |
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Objectives of Study: |
To evaluate the effect of Chinese herbal tea on the prevention of COVID-19 in returning workers in Wuhan. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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纳入标准: |
(1)男女性均可,18岁≦年龄≦75岁; (2)地域限定为湖北省武汉市; (3)自愿参加本项研究,并签署知情同意书。 |
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Inclusion criteria |
(1) Both male and female, 18 years old <= aged <= 75 years old; (2) The territory is limited to wuhan, hubei province; (3) Voluntarily participate in the study and sign the informed consent. |
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排除标准: |
(1)合并心、脑、肝、肾和造血系统等严重原发性疾病者; (2)合并肺部恶变者; (3)合并精神、智力或语言障碍者; (4)孕妇、哺乳期妇女及近6个月有妊娠要求者; (5)不能熟练使用手机、电脑等填写问卷资料者; (6)不愿意接受中药茶饮者,或既往有中药过敏史者; (7)服用其它中药茶饮者; (8)曾确诊COVID-19并痊愈者。 |
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Exclusion criteria: |
(1) People with severe primary diseases such as heart, brain, liver, kidney and hematopoietic system; (2) People with pulmonary malignancy; (3) Combined with mental, intellectual or language disorders; (4) Pregnant women, lactating women and those who have pregnancy requirement in the last 6 months; (5) People who cannot skillfully use mobile phones or computers to fill in the questionnaire; (6) People who are not willing to accept Chinese herbal tea, or those who have a history of allergy to Chinese herbal medicine; (7) People who are using other Chinese herbal tea; (8) People who had been diagnosed with covid-19 and recovered. |
研究实施时间: Study execute time: |
从From2020-04-16至To 2020-12-31 |
征募观察对象时间: Recruiting time: |
从From2020-04-16至To 2020-07-16 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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