Study for the improvement of the quality of life of severe patients of novel coronavirus pneumonia (COVID-19) by the integrated Chinese medicine and Western medicine therapy
- Conditions
- ovel Coronavirus Pneumonia (COVID-19)
- Registration Number
- ITMCTR2000003362
- Lead Sponsor
- Guangzhou Women and Children's Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. The novel coronavirus pneumonia, once diagnosed as a severe or critical illness, has been cured and discharged without any pathogen or rehabilitation;
2. It conforms to the above diagnostic standards of Western medicine and TCM syndrome differentiation;
3. The lung function indexes meet the following standards:
(1) the percentage of forced vital capacity in predicted value (FVC%) is between 50% - 90%;
(2) the percentage of carbon monoxide diffusion capacity in predicted value (DLCO%) is between 30% - 90%;
(3) the percentage of forced expiratory volume in FVC (FEV1 / FVC) within one second is not less than 80%; the oxygen partial pressure of the patient when resting and breathing indoor air is not less than 50mmhg;
4. Diagnostic criteria of pulmonary fibrosis: X-ray showed diffuse, asymmetric, reticular or reticular nodular shadows in both lungs, Fibrous cord shadow, strip or spot shadow, multiple light transmission area (honeycomb lung); CT showed two lower lobes of lung, especially the reticular shadow under pleura; pulmonary function examination showed restrictive ventilation dysfunction, decreased total lung volume and functional residual gas volume, normal or increased forced lung volume / active lung capacity in one second, decreased carbon monoxide in one breath method; thoracotomy or transthoracic lung biopsy It is considered as the gold standard for the diagnosis of pulmonary fibrosis;
5. Over 18 years of age;
6. Sign informed consent.
1. Patients with bronchiectasis, tuberculosis, asthma, chronic obstructive pulmonary disease, lung cancer and other primary lung diseases;
2. Progressive exacerbation of dyspnea symptoms in the past 6 months;
3. In the acute exacerbation stage of pulmonary fibrosis;
4. The random blood glucose level was more than 11.1mmol/l;
5. Patients with severe heart, brain, digestive system and mental diseases; patients with respiratory failure, severe peptic ulcer, malignant tumor, AIDS and autoimmune diseases;
6. Patients with bleeding tendency or severe hepatorenal insufficiency;
7. Those who have received or are using glucocorticoids, immunosuppressants and other drugs to treat pulmonary fibrosis or other diseases in the past 3 months;
8. In the past 3 months, he has received or is using traditional Chinese medicine with the functions of tonifying lung and kidney, promoting blood circulation and breaking blood stasis, eliminating phlegm and resolving stasis to treat pulmonary fibrosis or other diseases;
9. Pregnant, planned pregnant or lactating women, legally disabled persons, determine that the patients have survival risks due to other diseases and cannot complete the trial treatment;
10. In the past 3 months or in other clinical trials, those who are allergic to constitution or who are allergic to the use of traditional Chinese medicine, those who do not sign the informed consent, and those who are unable to judge the curative effect or incomplete information, which affect the judgment of curative effect or safety.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method weight;Borg Dyspnea Index;AGE;Total Vital Capacity;The Predicted Forced Vital Capacity;Forced Vital Capacity;Vital Capacity;The Predicted Diffusion Capacity for Carbon Monoxide;Diffusion Capacity for Carbon Monoxide;The maximum Vital Capacity;SCL-90 TABLE;Maximal Midle Expiratory Flow;SF-36 TABLE;6 min distance on foot;Immune factor;Immune cell;
- Secondary Outcome Measures
Name Time Method