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This study evaluated the effect of integrated traditional Chinese and Western medicine in the treatment of Severe COVID-19. The patients were randomly divided into experimental group and control group.
In this study, a multi center randomized controlled trial design was adopted, and the subjects were randomly divided into the experimental group and the control group. The control group was treated with western medicine conventional treatment plus traditional Chinese medicine decoction simulant, while the experimental group was treated with traditional Chinese medicine syndrome differentiation treatment decoction. The course of treatment was 14 days and the patients were followed up for 3 months. The clinical effect of integrated traditional Chinese and Western medicine treatment was evaluated from the aspects of 28 day mortality, 28 days without invasive mechanical ventilation, invasive mechanical ventilation rate, 28 days without ICU stay, clinical stability time, length of hospital stay, quality of life, SOFA score, etc., to clarify the clinical efficacy of integrated traditional Chinese and Western medicine treatment for Severe COVID-19 infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCM plus conventional drug | Experimental | The experimental group will receive three type of TCM inaddition conventional drug |
|
| TCM placebo plus conventional drug | Placebo Comparator | The control group will receive three type of placebo TCM inaddition conventional drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCM plus conventional drug | Drug | All patients were treated according to international guidelines. The Experimental group will receive TCM according to the TCM syndrome. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 28-day mortality | Proportion of patients who died of disease on day 28 | Mortality on the 28th day of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Days without invasive mechanical ventilation | Days without invasive mechanical ventilation in 28 days | the 28 days of the treatment phase |
| invasive mechanical ventilation rate | Rate of patients receiving invasive mechanical ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Henan University of Traditional Chinese Medicine | Zhengzhou | Henan | 450000 | China |
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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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| TCM placebo plus conventional drug | Drug | All patients were treated according to international guidelines. The control group will receive TCM placebo according to the TCM syndrome. |
|
| 28 days in the treatment phase |
| days of non-ICU | Calculate the number of days of patients not staying in ICU within 28 days | 28 days in the treatment phase |
| time to clinical stability | temperature of 37.2°C orlower, heart rate of 100 beats/min or lower, systolic blood pressure of 90 mm Hg or higher, and arterial oxygen tension of 60 mm Hg or higher when the patient was not receiving supplemental oxygen. | every day in the treatment. |
| hospitalization time | length of hospital stays will be recorded. | the 28 days of the treatment phase |
| Clinical status of patients 15 days after randomization | According to the 6-point clinical improvement scale of the World Health Organization, the lowest score was 1 and the highest was 6. The higher the score, the worse the result. | The clinical status of patients was observed 15 days after randomization. |
| Quality of life | Score according to the quality of life table,the minimum score is 12 points, and the maximum score is 60 points. The higher the score, the worse the result. | The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted. |
| TCM syndrome score | Traditional Chinese Medicine Syndrome Points.Including cough, expectoration, dyspnea, chest pain, anorexia and fatigue, each item is rated as 1-5 points from mild to severe.The minimum score is 6 points and the maximum score is 30 points. The higher the score, the worse the result. | The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted. |
| SOFA score | Sequential Organ Failure Assessment.It is a scoring system for evaluating and monitoring the organ function of critically ill patients.The minimum score is 0 and the maximum is 24. The higher the score, the worse the result. | The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |