Treatment of Pulmonary Fibrosis Due to COVID-19 With Fuzheng Huayu
- Conditions
- Pulmonary Fibrosis Due to COVID-19
- Interventions
- Drug: Fuzheng Huayu TabletDrug: PlaceboOther: respiratory function rehabilitation training
- Registration Number
- NCT04279197
- Lead Sponsor
- ShuGuang Hospital
- Brief Summary
According to previous studies, viral pneumonia can develop into pulmonary fibrosis, which can affect patients'lung function and even life health.This study aims to observe the efficacy and safety of Fuzheng Huayu Tablets in the treatment of pulmonary fibrosis after COVID-19.
- Detailed Description
The patients with COVID-19 could suffered from the pulmonary dysfunction and/or fibrosis the recovery period, but there are no certain drugs or treatment to cope with this situation. Our previous studies indicated that Fuzheng Huayu tablets (FZHY) could regress the lung fibrosis induced by bleomycin in animals, and improve the pulmonary function in the patients with chronic obstructive pulmonary disease. Now we design this trial to carry out the clinical study in order to evaluate the effects of Fuzheng Huayu tablets on pulmonary fibrosis and/or pulmonary function injury in the recovery period of COVID-19 and expect to improve the prognosis.
This is a randomized, double-blind, multicenter, placebo-controlled clinical trial.It enrolls 142 patients who had been diagnosed with COVID-19, but currently they are negative for viral testing and have developed pulmonary fibrosis or pulmonary dysfunction. They are randomly assigned into Placebo group and FZHY group. All patients are given usual treatment such as respiratory function rehabilitation training and vitamin C. The FZHY group is given Fuzheng Huayu tablets, and the control group is given placebo. Each patient will be observed for 24 weeks and followed up for 8 weeks. The primary outcomes for the trial are the improvement proportion of pulmonary fibrosis judged by HRCT score and the improvement of lung function(FVC,FEV1,FVC/FEV1). Secondary outcomes include six-minute walk distance, improvement proportion of pulmonary inflammation, improvement proportion of clinical symptoms , quality of Life-BREF (QOL-BREF) Score, patient health questionnaire-9 (PHQ-9) Score, general anxiety disorder-7 (GAD-7) score. The safety also be observed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 142
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FZHY Group Vitamin C tablets usual treatment (respiratory function rehabilitation training + Vitamin C tablets) * Fuzheng Huayu tablets FZHY Group respiratory function rehabilitation training usual treatment (respiratory function rehabilitation training + Vitamin C tablets) * Fuzheng Huayu tablets Placebo Group Vitamin C tablets usual treatment (respiratory function rehabilitation training + Vitamin C tablets) * placebo FZHY Group Fuzheng Huayu Tablet usual treatment (respiratory function rehabilitation training + Vitamin C tablets) * Fuzheng Huayu tablets Placebo Group Placebo usual treatment (respiratory function rehabilitation training + Vitamin C tablets) * placebo Placebo Group respiratory function rehabilitation training usual treatment (respiratory function rehabilitation training + Vitamin C tablets) * placebo
- Primary Outcome Measures
Name Time Method The improvement proportion of pulmonary fibrosis Week 24 Evaluation of pulmonary fibrosis Improvement. pulmonary fibrosis judged by HRCT score.HRCT images are divided into four grades according to the score, and a reduction of one grade is an improvement.
The improvement of lung function Week 24 FVC, FEV1, FVC/FEV1
- Secondary Outcome Measures
Name Time Method The improvement proportion of clinical symptom Week 24 Discomfort symptoms include dyspnea, cough, exhausted, fatigue, insomnia, sweating, poor appetite, diarrhea, etc., which are common manifestations of patients with COVID-19
Patient Health Questionnaire-9(PHQ-9) Week 24 This scale can reflect the quality of life of patients to some extent.
The 6-minute walk distance Week 24 Evaluation of Lung Function Improvement
Quality of Life-BREF (QOL-BREF) Week 24 This scale can reflect the quality of life of patients to some extent.
The improvement proportion of pulmonary inflammation Week 24 Evaluation of pulmonary inflammation Improvement
Generalized anxiety disorder-7(GAD-7) Week 24 This scale can reflect the quality of life of patients to some extent.
Trial Locations
- Locations (1)
Shuguang Hospital
🇨🇳Shanghai, Shanghai, China