The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, 450000, China
NCT Number: NCT06714032
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.
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All sexes
Interventional
Phase 3
Zhengzhou, Henan, 450000, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All patients were treated according to international guidelines. The Experimental group will receive TCM according to the TCM syndrome.
All patients were treated according to international guidelines. The control group will receive TCM placebo according to the TCM syndrome.
Time frame: Mortality on the 28th day of treatment
Proportion of patients who died of disease on day 28
Time frame: the 28 days of the treatment phase
Days without invasive mechanical ventilation in 28 days
Time frame: 28 days in the treatment phase
Rate of patients receiving invasive mechanical ventilation
Time frame: 28 days in the treatment phase
Calculate the number of days of patients not staying in ICU within 28 days
Time frame: every day in the treatment.
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.
Time frame: the 28 days of the treatment phase
length of hospital stays will be recorded.
Time frame: The clinical status of patients was observed 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.
Time frame: The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted.
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.
Time frame: The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted.
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.
Time frame: The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted
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.
Henan University of Traditional Chinese Medicine
Other
Integrated Traditional Chinese and Conventional Medicine in Treatment for Patients with Severe COVID-19: Study Protocol for a Randomized Controlled Trial
Acronym: COVID-19
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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