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To evaluate the efficacy and safety of Anluohuaxian in blocking the progression of pulmonary fibrosis and improving lung function in patients with COVID-19.
In clinical institutions that enroll patients with corona virus disease 2019, two arms, multi-center, randomized and controlled methods are adopted. Patients are divided into two groups, Anluohuaxian combined with regular treatment group and regular treatment group. 750 patients are expected to be enrolled and the cases are allocated according to the ratio of 2( Anluohuaxian combined with regular treatment group): 1(regular treatment group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anluohuaxian combined with regular treatment group | Experimental | Anluohuaxian: 6g each time, twice a day |
|
| regular treatment group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anluohuaxian | Drug | 6g each time, twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in high-resolution computer tomography of the lung | Changes in ground-glass shadows, interstitial or air nodules found on high-resolution computer tomography | 3 months |
| Change in 6-minute walking distance | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in compound physiological index | 3 months | |
| Changes in the scores of the St. George's Hospital Respiratory Questionnaire | St. George's Hospital Respiratory Questionnaire range from 0 to 100. 0 stands for no impact on life and 100 stands for extreme impact on life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guiqiang Wang | Contact | 13911405123 | john131212@sina.com | |
| Hong Zhao | Contact | 13810765943 | zhaohong_pufh@bjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Guiqiang Wang | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second People's Hospital of Fuyang | Not yet recruiting | Fuyang | Anhui | 230022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32513299 | Derived | Zhang C, Li J, Wu Z, Wang H, Que C, Zhao H, Wang G. Efficacy and safety of Anluohuaxian in the treatment of patients with severe Coronavirus disease 2019- a multicenter, open label, randomized controlled study: a structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jun 8;21(1):495. doi: 10.1186/s13063-020-04399-8. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000708108 | anluohuaxian |
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| 3 months |
| Changes in modified British Medical Research Council Dyspnea Scale (mMRC) scores | mMRC score range from 0 to 4. 0 stands for wheezing only when exercising hard and 4 stands for severe breathing difficulties. | 3 months |
| Changes in vital capacity of the lung | Adult male vital capacity is about 3,500 ml and female is about 2,500 ml. | 3 months |
| Ezhou Central Hospital | Not yet recruiting | Wuhan | Hubei | 430000 | China |
|
| Huoshenshan Hospital of Wuhan | Not yet recruiting | Wuhan | Hubei | 430000 | China |
|
| Jinyintan Hospital of Wuhan | Recruiting | Wuhan | Hubei | 430000 | China |
|
| Tongji Hospital of Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | 430000 | China |
|
| West Hospital Union Hospital Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | 430000 | China |
|
| Wuhan Pulmonary Hospital | Not yet recruiting | Wuhan | Hubei | 430000 | China |
|
| Zhongnan Hospital of Wuhan University | Not yet recruiting | Wuhan | Hubei | 430000 | China |
|
| Wenzhou Medical University Affiliated First Hospital | Not yet recruiting | Wenzhou | Zhejiang | 325000 | China |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |