An Early Phase 1 interventional study of Yinhu Qingwen Granules in Viral Pneumonia, sponsored by Zhong Wang. Status unknown at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-15.
Sponsored by Zhong Wang · Early Phase 1, Interventional, and Treatment
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.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's planned enrollment of 60 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Zhong Wang is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
For mild and common patients, take 1 bag 2 times a day. For severe patients, take 1 bag 3 times a day.
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
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
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Zhong Wang