注册号: Registration number: |
ChiCTR2000032313 |
最近更新日期: Date of Last Refreshed on: |
2020-04-26 |
注册时间: Date of Registration: |
2020-04-25 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
桔杏君子颗粒干预新型冠状病毒肺炎(COVID-19)恢复期患者的疗效与安全性评价 |
Public title: |
Study for efficacy and safety of Jie-Xing-Jun-Zi granules in the Treatment of convalescent patients of novel coronavious pneumonia (COVID-19) |
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: |
桔杏君子颗粒干预新型冠状病毒肺炎恢复期患者的疗效与安全性评价 |
Scientific title: |
Study for efficacy and safety of Jie-Xing-Jun-Zi granules in the Treatment of convalescent patients of novel coronavious pneumonia (COVID-19) |
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: |
ChiMCTR2000003243 |
申请注册联系人: |
秦欣欣 |
研究负责人: |
崔红生 |
Applicant: |
Xinxin Qin |
Study leader: |
Hongsheng Cui |
申请注册联系人电话: Applicant telephone: |
+86 15600790166 |
研究负责人电话: Study leader's telephone: |
+86 13901101359 |
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: |
qinxinxin1992@126.com |
研究负责人电子邮件: Study leader's E-mail: |
hshcui@sina.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: |
北京市朝阳区安外小关街51号 |
研究负责人通讯地址: |
北京市朝阳区安外小关街51号 |
Applicant address: |
51 Anwai Xiaoguan Street, Chaoyang District, Beijing, China |
Study leader's address: |
51 Anwai Xiaoguan Street, Chaoyang 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: |
北京中医药大学第三附属医院 |
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Applicant's institution: |
Beijing University of Chinese Medicine, Third Affiliated Hospital |
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: |
ECBJZYYKJFZZJSL-ZYDSY2020-01 |
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: |
北京中医药大学第三附属医院科研伦理委员会 |
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Name of the ethic committee: |
Scientific Research Ethics Committee of Beijing University of Chinese Medicine Third Affiliated Hospital |
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伦理委员会批准日期: Date of approved by ethic committee: |
2020-04-01 | ||
伦理委员会联系人: |
赵莹 |
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Contact Name of the ethic committee: |
Ying Zhao |
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伦理委员会联系地址: |
北京市朝阳区安外小关街51号 |
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Contact Address of the ethic committee: |
51 Anwai Xiaoguan Street, Chaoyang District, Beijing, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 010 84980751 |
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: |
北京中医药大学第三附属医院 |
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Primary sponsor: |
Beijing University of Chinese Medicine Third Affiliated Hospital |
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研究实施负责(组长)单位地址: |
北京市朝阳区安外小关街51号 |
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Primary sponsor's address: |
51 Anwai Xiaoguan Street, Chaoyang 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: |
自筹 |
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Source(s) of funding: |
Self-financing |
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研究疾病: |
新型冠状病毒肺炎(COVID-19) |
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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: |
探索性研究/预试验 | ||||||||||||||||||||||
Study phase: |
0 |
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研究目的: |
评价桔杏君子颗粒干预治疗新冠肺炎恢复期患者的有效性和安全性。 |
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Objectives of Study: |
To evaluate the efficacy and safety of Juxingjunzi Granules in the interventional treatment of patients with novel coronavious pneumonia in the recovery period. |
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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)符合新冠状病毒肺炎恢复期患者,年龄在18-75岁; (2)符合气阴两伤,余邪未尽证候诊断标准; (3)自愿受试,或直系亲属或患者认可的委托人同意受试,并自愿签署知情同意书; (4)能提供详细联络方式,无短期迁移意愿,能够愿意配合随访者。 |
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Inclusion criteria |
(1) Convalescent patients with novel coronavious pneumonia,and the patient is aged 18-75 years old; (2) The TCM syndrome type conforms to deficiency of 'qi' and 'yin' and not exhausted of 'Yu Xie'; (3) Voluntary test, or the immediate family or the client's approved client agrees to the test, and voluntarily signs the informed consent; (4) Provide detailed contact information, no short-term willingness to move and be willing to cooperate with followers. |
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排除标准: |
(1)因消化道出血、肠梗阻等禁食水的患者; (2)原有严重脑、心、肝、肾和造血系统等疾病不能配合者; (3)已知的对干预药物成分过敏者; (4)无法配合随访者。 |
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Exclusion criteria: |
(1) Patients with fasting water due to gastrointestinal bleeding, intestinal obstruction, etc; (2) Patients with pre-existing severe brain, heart, liver, kidney and hematopoietic system diseases; (3) Patients who are known to be allergic to the ingredients of the intervention drug; (4) Patients who are unable to cooperate with follow-up. |
研究实施时间: Study execute time: |
从From2020-05-01至To 2020-12-31 |
征募观察对象时间: Recruiting time: |
从From2020-05-01至To 2020-12-01 |
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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