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Evaluation of the efficacy and safety of TCM differential treatment of COVID-19 in Jiangsu Province based on the historical prospective multicenter cohort study.
This is a multi-center cross-sectional syndrome investigation study, taking confirmed cases as the main observation object, A prospective multicenter cohort study was designed, focusing on the common type with the largest number of confirmed cases, to evaluate the intervention effect of this project in relieving the disEvaluation of the efficacy and safety of TCM differential treatment of COVID-19 inease and preventing disease progressio.
According to the actual situation of receiving treatment, if the subjects received the combination of western medicine and traditional Chinese medicine, it was the exposure group (integrated traditional Chinese and western medicine cohort), and if the subjects only received western medicine treatment, it was the control group (western medicine cohort). The choice of treatment for patients is entirely determined by clinicians according to the patient's condition, and patients are free to choose after fully understanding different schemes).The choice of control group: COVID-19 (common type) who received routine treatment + antiviral therapy;The choice of exposure group: COVID-19 (common type) who received routine treatment + TCM.The sample size is tentatively set at 340.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort of western medicine |
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| |
| Cohort of integrated TCM and western medicine | routine treatment + Antiviral drugs + the following TCM regimens. 1.TCM regimens:① Early stage: Dampness trapped in exterior and interior. Recommended prescription: Huoxiang 15g, Suye15g, Cangzhu15g, Houpo10g, Qianhu15g, Chaihu15g, Huangqin10g, Qinghao20g, Xingren10g, JInyinhua15g, Lianqiao15g. Take decocted or granule, one dose a day. ② Middle stage: Dampness-toxicity blocking lung Recommended prescription: Zhimahuang9g, Xingren10g, Sangbaipi30g, Tinglizi20g, Dongguazi20g, Fabanxia10g, Houpo10g, Suzi15g, Baijiezi10g, Gualoupi15g, Xuanfuhua9g, Xiangfu10g, Yujin10g, Taoren10g, Huangqi20g. Take decocted or granule, one dose a day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCM prescriptions | Drug | TCM prescriptions1:Take decocted or granule, one dose a day; TCM prescriptions2:Take decocted or granule, one dose a day. |
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| Measure | Description | Time Frame |
|---|---|---|
| The relief of main symptoms/ disappearance rate of time | comparison of the time of relief / disappearance of three main symptoms of fever, cough and shortness of breath | 9day |
| Chest CT absorption | with reference to the "pneumonia chest X-ray absorption Evaluation scale" developed by Renyi Yin et al, the final absorption judgment will be used to evaluate the chest CT absorption of patients with pneumonia, which is divided into four levels according to the degree of absorption: complete absorption, majority absorption, partial absorption and no absorption. | 9day |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation standard of comprehensive curative effect | With reference to the "Therapeutic effect Standard for diagnosis and Syndrome of Traditional Chinese Medicine" and "guiding principles for Clinical Research of New drugs of traditional Chinese Medicine", the final evaluation was based on clinical remission. | 9day |
| Measure | Description | Time Frame |
|---|---|---|
| CRP changes | Changes in c-reactive protein. | 9day |
| ESR changes | Changes in erythrocyte sedimentation rate. | 9day |
Inclusion Criteria:
Exclusion Criteria:
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It conforms to the diagnostic criteria of confirmed cases of COVID-19.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huai'an fourth people's Hospital | Huaian | Jiangsu | 210029 | China |
All researchers in this study
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Virus antigen negative conversion rate |
the detection negative rate of nasopharyngeal swab, conjunctival sac secretion virus nucleic acid. |
| 9day |
| The number of severe and critical conversion cases | the number of severe and critical cases occurred after the start of intervention. | 9day |
| Incidence of complications | defined as complications during isolation and hospitalization due to pneumonia infected by novel coronavirus, including bacterial infection, aggravation of underlying diseases, etc | 9day |
| Traditional Chinese Medicine Syndrome Score | According to the Traditional Chinese Medicine symptom score scale, the change of symptom score before and after treatment was observed.The highest score was 92 points, and the lowest was 23 points. The higher the score, the more severe the symptoms. | 9day |
| PCTchanges | Changes in procalcitonin. | 9day |
| The index of T cell subsets changed | Changes of CD4+ and CD8+ | 9day |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |