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This is a non-randomized single arm clinical study to observe the effect of Yinhu Qingwen Granule in the relief of fever and improvement of related-symptoms of patients with viral pneumonia.
Preliminary pharmacodynamic and toxicological studies can show that Yinhu Qingwen Granule has a certain effect on pneumonia caused by various viruses, and its safety is good. This study aims to observe the effect of Yinhu Qingwen Granule in the relief of fever and improvement of related-symptoms of patients with viral pneumonia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yinhu Qingwen Granule | Experimental | For mild and common patients, take 1 bag 2 times a day. For severe patients, take 1 bag 3 times a day. All treatment should be used for 10 days unless all the symtopms of patient with the viral pneumonia are relieved. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yinhu Qingwen Granules | Drug | For mild and common patients, take 1 bag 2 times a day. For severe patients, take 1 bag 3 times a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to the normalization of the temperature | The normalization of the temperature is defined as that the temperature of the patient dropped to normal and stabilized for more than 72 hours. | up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to cough reported as mild or absent | The severity of cough is assessed using Cough Symptom Scale, a scale range from 0-6. 0: cough absent;1-2: mild; 3-4:moderate; 5-6: severe | Baseline, Day 3, Day 7, Day 10 and Day 30 |
| Mean clinical recovery time (hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhong Wang, M.D. | Contact | +861064093305 | zhonw@vip.sina.com | |
| Jun Liu, Ph.D. | Contact | +861064093207 | franlj1104@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Chengdu University of Traditional Chinese Medicine | Chengdu | Sichuan | 610072 | China |
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| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
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The clinical recovery time is defined as the time from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours. Normalisation and alleviation criteria: (1) Fever: ≤36.6°C or -axilla, ≤37.2 °C oral or ≤37.8°C rectal or tympanic;(2)Respiratory rate - ≤24/minute on room air; 3) Oxygen saturation - >94% on room air; (4) Cough - mild or absent on a patient reported scale (cough symptoms score ≤ 2 points). |
| up to 30 days |
| Time to dyspnea reported as mild or absent | The severity of dyspnea is assessed on a self-reported scale of severe, moderate, mild or absent. | Baseline, Day 3, Day 7, Day 10 and Day 30 |
| Mean blood oxygen saturation | Baseline, Day 3, Day 7, Day 10 |
| Mean neutrophil/lymphocyte ratio (NLR) | Neutrophil/lymphocyte ratio (NLR) is obtained from the blood routine. | Baseline, Day 10 |
| Frequency of requirement for supplemental oxygen or non-invasive ventilation | up to 30 days |
| Mean time of supplemental oxygen (days) | up to 30 days |
| Mean time of non-invasive ventilation (days) | up to 30 days |
| Severe case incidence | Severe case is defined as respiratory rate ≥30/minute on room air;or Oxygen saturation - ≤94% on room air;or PaO2/FiO2≤300mmHg. | up to 30 days |
| Proportion of re-hospitalization or admission to ICU | up to 30 days |
| All-cause mortality | up to 30 days |
| Frequency of serious adverse events | up to 30 days |
| Chengdu First People's Hospital/Chengdu integrated TCM & Western Medicine Hospital | Chengdu | Sichuan | 610095 | China |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |