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Efficacy of the combination of modern medicine and traditional Chinese medicine in pulmonary fibrosis arising as a sequelae in convalescent COVID-19 patients: a randomized multicenter trial
- Source :
- Infectious Diseases of Poverty, Infectious Diseases of Poverty, Vol 10, Iss 1, Pp 1-13 (2021)
- Publication Year :
- 2020
-
Abstract
- Background The coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has led to a significant number of mortalities worldwide. COVID-19 poses a serious threat to human life. The clinical manifestations of COVID-19 are diverse and severe and 20% of infected patients are reported to be in a critical condition. A loss in lung function and pulmonary fibrosis are the main manifestations of patients with the severe form of the disease. The lung function is affected, even after recovery, thereby greatly affecting the psychology and well-being of patients, and significantly reducing their quality of life. Methods Participants must meet the following simultaneous inclusion criteria: over 18 years of age, should have recovered from severe or critical COVID-19 cases, should exhibit pulmonary fibrosis after recovery, and should exhibit Qi-Yin deficiency syndrome as indicated in the system of traditional Chinese medicine (TCM). The eligible candidates will be randomized into treatment or control groups. The treatment group will receive modern medicine (pirfenidone) plus TCM whereas the control group will be administered modern medicine plus TCM placebo. The lung function index will be continuously surveyed and recorded. By comparing the treatment effect between the two groups, the study intend to explore whether TCM can improve the effectiveness of modern medicine in patients with pulmonary fibrosis arising as a sequelae after SARS-CoV-2 infection. Discussion Pulmonary fibrosis is one of fatal sequelae for some severe or critical COVID-19 cases, some studies reveal that pirfenidone lead to a delay in the decline of forced expiratory vital capacity, thereby reducing the mortality partly. Additionally, although TCM has been proven to be efficacious in treating pulmonary fibrosis, its role in treating pulmonary fibrosis related COVID-19 has not been explored. Hence, a multicenter, parallel-group, randomized controlled, interventional, prospective clinical trial has been designed and will be conducted to determine if a new comprehensive treatment for pulmonary fibrosis related to COVID-19 is feasible and if it can improve the quality of life of patients. Trial registration: This multicenter, parallel-group, randomized controlled, interventional, prospective trial was registered at the Chinese Clinical Trial Registry (ChiCTR2000033284) on 26th May 2020 (prospective registered).
- Subjects :
- Data Analysis
medicine.medical_specialty
Modern medicine
SASR-CoV-2
Pulmonary Fibrosis
Traditional Chinese medicine
Placebo
Antiviral Agents
lcsh:Infectious and parasitic diseases
03 medical and health sciences
Study Protocol
0302 clinical medicine
Quality of life
Internal medicine
Multicenter trial
Pulmonary fibrosis
medicine
lcsh:RC109-216
030212 general & internal medicine
Medicine, Chinese Traditional
business.industry
SARS-CoV-2
lcsh:Public aspects of medicine
Public Health, Environmental and Occupational Health
COVID-19
lcsh:RA1-1270
General Medicine
Pirfenidone
medicine.disease
Combined Modality Therapy
Clinical trial
Infectious Diseases
Treatment Outcome
030220 oncology & carcinogenesis
Quality of Life
business
medicine.drug
Subjects
Details
- ISSN :
- 20499957 and 20000332
- Volume :
- 10
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Infectious diseases of poverty
- Accession number :
- edsair.doi.dedup.....9c8f76a77adecfe17989097e31d7e5b6