ITMCTR2000003362尚未招募1 期
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
Guangzhou Women and Children's Medical Center0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 90（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
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