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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
For mild and common patients, take 1 bag 2 times a day. For severe patients, take 1 bag 3 times a day.
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China
Chengdu First People's Hospital/Chengdu integrated TCM & Western Medicine Hospital
Chengdu, Sichuan, China
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.
Time frame: up to 30 days
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
Time frame: 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).
Time frame: 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.
Time frame: Baseline, Day 3, Day 7, Day 10 and Day 30
Mean blood oxygen saturation
Time frame: Baseline, Day 3, Day 7, Day 10
Mean neutrophil/lymphocyte ratio (NLR)
Neutrophil/lymphocyte ratio (NLR) is obtained from the blood routine.
Time frame: Baseline, Day 10
Frequency of requirement for supplemental oxygen or non-invasive ventilation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to 30 days
Mean time of supplemental oxygen (days)
Time frame: up to 30 days
Mean time of non-invasive ventilation (days)
Time frame: 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.
Time frame: up to 30 days
Proportion of re-hospitalization or admission to ICU
Time frame: up to 30 days
All-cause mortality
Time frame: up to 30 days
Frequency of serious adverse events
Time frame: up to 30 days