Status:
COMPLETED
Clinical Trial Scheme of Tanreqing Capsules in the Treatment of COVID-19
Lead Sponsor:
Jiangsu Famous Medical Technology Co., Ltd.
Collaborating Sponsors:
Ruijin Hospital
Conditions:
Novel Coronavirus Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study was conducted in a randomized, double-blind, placebo-controlled, multicenter clinical trial design. Two groups were designed, the experimental group and the placebo control group. Patients ...
Detailed Description
The purpose of this study was to evaluate the efficacy and safety of Tanreqing capsule in the treatment of mild and common COVID-19. The trial was a randomized, double-blind, placebo-controlled, multi...
Eligibility Criteria
Inclusion
- According to the Diagnosis and Treatment Plan for Pneumonia Infected by novel coronavirus (Trial Version 9), those who are in line with the diagnosis of novel coronavirus pneumonia and whose clinical classification is light and ordinary；
- Aged greater than 18, with no gender limitation;
- Symptom score greater than or equal 3 points;
- Voluntarily accept the drug treatment and sign the informed consent.
Exclusion
- Patients with severe primary respiratory diseases or other pathogenic microbial pneumonia that needs to be differentiated from COVID-19;
- immune deficiency disease, or use of immunosuppressants or glucocorticoids in the last 3 months;
- pregnant and lactating women;
- People with allergic constitution (allergic to more than two drugs or food or known allergic to the drug used in this study);
- mentally ill persons or persons without self-awareness;
- Patients whose expected survival time from screening is not more than 48 hours; (7) those who have been intubated or mechanically ventilated at the time of screening;
- (8) In patients with serious primary diseases of heart, brain, liver and kidney, ALT and AST were 1.5 times higher than the upper limit of normal value; (9) Other conditions that the investigator considers inappropriate for clinical trial participation.
Key Trial Info
Start Date :
March 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT05305456
Start Date
March 28 2022
End Date
August 31 2022
Last Update
December 6 2022
Active Locations (2)
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1
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200040
2
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China, 200093