Yinhu Qingwen Granule in the Treatment of Viral Pneumonia
- Registration Number
- NCT04955223
- Lead Sponsor
- Zhong Wang
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Yinhu Qingwen Granule 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. All treatment should be used for 10 days unless all the symtopms of patient with the viral pneumonia are relieved.
- Primary Outcome Measures
Name Time Method Time to the normalization of the temperature up to 30 days The normalization of the temperature is defined as that the temperature of the patient dropped to normal and stabilized for more than 72 hours.
- Secondary Outcome Measures
Name Time Method Time to cough reported as mild or absent Baseline, Day 3, Day 7, Day 10 and Day 30 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
Mean clinical recovery time (hours) up to 30 days 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 to dyspnea reported as mild or absent Baseline, Day 3, Day 7, Day 10 and Day 30 The severity of dyspnea is assessed on a self-reported scale of severe, moderate, mild or absent.
Mean blood oxygen saturation Baseline, Day 3, Day 7, Day 10 Mean neutrophil/lymphocyte ratio (NLR) Baseline, Day 10 Neutrophil/lymphocyte ratio (NLR) is obtained from the blood routine.
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 up to 30 days Severe case is defined as respiratory rate ≥30/minute on room air；or Oxygen saturation - ≤94% on room air；or PaO2/FiO2≤300mmHg.
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
Trial Locations
- Locations (2)
Chengdu First People's Hospital/Chengdu integrated TCM & Western Medicine Hospital
🇨🇳Chengdu, Sichuan, China
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
🇨🇳Chengdu, Sichuan, China