Treatment of Pulmonary Fibrosis Due to COVID-19 With Fuzheng Huayu
NCT ID: NCT04279197
Last Updated: 2022-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
142 participants
INTERVENTIONAL
2020-04-23
2021-03-24
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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FZHY Group
usual treatment (respiratory function rehabilitation training + Vitamin C tablets)
* Fuzheng Huayu tablets
Fuzheng Huayu Tablet
FZHY, administration: 0.4g/tablet, 1.6g/time, 3 times/day, oral; administered half an hour after the meal.
Vitamin C tablets
Vitamin C tablets, administration: 0.2g/time, 3 times/ day, oral；
respiratory function rehabilitation training
Health exercise, once a day
Placebo Group
usual treatment (respiratory function rehabilitation training + Vitamin C tablets)
* placebo
Vitamin C tablets
Vitamin C tablets, administration: 0.2g/time, 3 times/ day, oral；
Placebo
Placebo , administration: 0.4g/tablet, 1.6g/time, 3 times/day, oral; administered half an hour after the meal.
respiratory function rehabilitation training
Health exercise, once a day
Interventions
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Fuzheng Huayu Tablet
FZHY, administration: 0.4g/tablet, 1.6g/time, 3 times/day, oral; administered half an hour after the meal.
Vitamin C tablets
Vitamin C tablets, administration: 0.2g/time, 3 times/ day, oral；
Placebo
Placebo , administration: 0.4g/tablet, 1.6g/time, 3 times/day, oral; administered half an hour after the meal.
respiratory function rehabilitation training
Health exercise, once a day
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* Relying on mechanical ventilation to maintain pulmonary function, such as ventilators;
* Combined with chronic pulmonary diseases affecting pulmonary function, such as chronic obstructive pulmonary disease, other known causes of interstitial pulmonary disease;
* Patients with diseases affecting cardiac function, such as pulmonary circulation hypertension, heart failure, peripheral vascular disease, fibromyalgia, and pacemaker installation;
* Patients with severe underlying diseases affecting survival, including uncontroled cardiac, renal, digestive, hematological, neuropsychiatric, immune, metabolic diseases, malignant diseases and severe malnutrition;
* Resting heart rate \>120 times/min;
* Systolic blood pressure \> 180 mmHg, diastolic blood pressure \> 100 mmHg;
* Unstable angina pectoris or myocardial infarction occurring within the last month;
* Severe obesity (BMI \> 30 kg/m2);
* Allergic constitution, allergic to the drug components involved in the treatment program;
* Pregnant or breastfeeding women;
* Patients with disabilities who are unable to complete the efficacy evaluation questionnaires;
* Difficult collaborators with poor mental health status, suffering from mental illness, patients without self-control, unable to express clearly;
* Those who are participating in other clinical trials;
* According to the investigator's judgment, patients whose enrollment complications or poor compliance will affect the efficacy and safety evaluation.
18 Years
70 Years
ALL
No
Sponsors
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Hubei Hospital of Traditional Chinese Medicine
OTHER
Jingmen No.1 People's Hospital
OTHER
Wuhan No.1 Hospital
OTHER
Wuhan Third Hospital
OTHER
Huangshi Hospital of Traditional Chinese Medicine
UNKNOWN
ShuGuang Hospital
OTHER
Responsible Party
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Liu Chenghai
Institute Director
Principal Investigators
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Chenghai Liu
Role: STUDY_DIRECTOR
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Locations
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Shuguang Hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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Jing F, Wang W, Ke J, Huang T, Jiang B, Qiu Q, Huang J, Zhan S, Zhang W, Wu H, Su W, Feng J, Peng Y, Zhao Z, Xing F, Liu C. Fuzheng Huayu tablets for treating pulmonary fibrosis in post-COVID-19 patients: a multicenter, randomized, double-blind, placebo-controlled trial. Front Pharmacol. 2025 Mar 11;16:1508276. doi: 10.3389/fphar.2025.1508276. eCollection 2025.
Other Identifiers
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Fzhy-ncp-2
Identifier Type: -
Identifier Source: org_study_id
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