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.
Drug: TCM prescriptions
TCM prescriptions1:Take decocted or granule, one dose a day; TCM prescriptions2:Take decocted or granule, one dose a day.
Inclusion Criteria:
- It conforms to the diagnostic criteria of confirmed cases of COVID-19 that belongs to
the common type;
- The age ranges from 18 to 80 years old, regardless gender；
- In the prospective study, the patient informed consent and sign the informed consent
form (if the subject has no capacity, limited capacity and limited expression of
personal will, he or she should obtain the consent of his guardian and sign the
informed consent at the same time), the retrospective study is visa-free informed
consent.
Exclusion Criteria:
- Women during pregnancy or lactation;
- Allergic constitution, such as those who have a history of allergy to two or more
drugs or food, or who are known to be allergic to drug ingredients observed in this
study.
- Severe complications such as multiple organ failure and shock occurred.
- Complicated with severe primary diseases such as heart, brain, liver, kidney and so
on.
- Patients have mental illness.
- Patients who participated in or is currently participating in other clinical trials
within the first month of this study.
Huai'an fourth people's Hospital
Huaian, Jiangsu, China