Yinhu Qingwen Granule in the Treatment of Viral Pneumonia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Non-random Single-arm Clinical Study of Yinhu Qingwen Granule in the Treatment of Viral Pneumonia

Conditions
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Viral Pneumonia

Intervention / Treatment
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* Drug: Yinhu Qingwen Granules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of viral pneumonia; Clinical diagnosis of Shi-du-yun-jie Zheng (damp stagnation syndrome) according to Chinese medicine, including fever,cough,sore throat,stuffy chest,irritability and thirst,short yellow urine,constipation or loose stool,thick and greasy yellow coating,and slippery pulse; Chest CT showed signs of acute exudative pneumonia in the lungs; Over 18 years old, regardless of gender, voluntarily signed an informed consent form; Those who were hospitalized and were accompanied by fever (body temperature ≥37.3℃) and respiratory tract symptoms like cough or dyspnea, when they were enrolled. Exclusion Criteria: Patients that are susceptible to sensitivity or known to be allergic to the study drug; Patients whose white blood cell count ≥12×10^9 or neutrophil percentage ≥80%; Patients whose weight is less than 40 kg; Patients with respiratory failure or need mechanical ventilation; Patients with shock; Patients required to be in ICU monitoring and treatment; Patients participated in other clinical trials within 1 month; Patients with known renal impairment; Patients with any of the following laboratory parameter abnormalities during the screening period or within 24 hours before screening: ALT or AST level> 5 times the upper limit of normal range (ULN) or-ALT or AST level > 3 times ULN and total bilirubin level> 2 times ULN; Patients with immune system diseases and long-term use of immunosuppressive agents; Pregnant or breastfeeding women, or who have a positive pregnancy test during the screening period, or plan to become pregnant within 3 months after the study treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yinhu Qingwen Granule<br>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. | Drug: Yinhu Qingwen Granules<br>* For mild and common patients, take 1 bag 2 times a day. For severe patients, take 1 bag 3 times a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |