Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 65 Years|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Pulmonary Fibrosis Due to 2019-nCoV|
Corona Virus Disease 2019, which began in December 2019 in Wuhan, Hubei province, has spread rapidly and become an international public health emergency. Although the pathological mechanism of the pneumonia is unclear, some patients developed severe or critical condition due to the continuous development of inflammation. Inflammation is the early stage of fibrosis. After the control of acute symptoms and signs, severe patients often have more manifestations of pulmonary fibrosis, which affects the recurrence of lung function. Fuzheng Huayu tablets has been proved effective in inhibiting MMP activity to protect subepithelial basement membrane which plays a key role in lung injury and interstitial fibrosis. This is a randomized, double blind, multicenter clinical study of pulmonary fibrosis due to 2019-nCoV. The main objective is to evaluate the safety and efficacy of Fuzheng Huayu in pulmonary fibrosis after 2019-nCoV infection. In this study, 136 eligible patients with pulmonary fibrosis due to 2019-nCoV infection will be randomly assigned to one of two treatment groups at a 1:1 ratio. Patients will receive one of two treatment regimens: A. Fuzheng Huayu tablets + basic treatment; B. Placebo tablets + basic treatment. The basic treatment includes N-acetylcysteine 1 capsule three times a day.
Experimental: Basic Treatment+Fuzheng Huayu Tablet
Capcule with N-acetylcysteine+ Tablet with Fuzheng Huayu
Placebo Comparator: Basic Treatment+Placebo
Capcule with N-acetylcysteine+ Tablet with starch
Drug: - N-acetylcysteine+ Fuzheng Huayu Tablet
The subjects will be taking 1 N-acetylcysteine capcule and 4 Fuzheng Huayu tablets three times a day for 24 weeks.
Drug: - N-acetylcysteine+Placebo
The subjects will be taking 1 N-acetylcysteine capcule and 4 Placebo tablets three times a day for 24 weeks.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.