Clinical Trial Scheme of Tanreqing Capsules in the Treatment of COVID-19
Study Details
Study Description
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 in both groups received basic treatment with vitamin C effervescent tablets. Tanreqing capsule was added to basic treatment in the experimental group, and placebo was added to basic treatment in the control group. The treatment course was 7 days, and the observation period was set to 7 days, with a daily visit.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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, multicenter clinical trial design. A total of 480 patients were divided into 2 groups: experimental group and control group 3:1. Patients in both groups received basic treatment with vitamin C effervescent tablets. Tanreqing capsule was added to basic treatment in the experimental group, and placebo was added to basic treatment in the control group. The treatment course was 7 days, and the observation period was set to 7 days, with a daily visit.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tanreqing capsule 3 capsules per time, 3 times a day，7 days of treatment |
Drug: Tanreqing capsule
3 capsules per time, 3 times a day
Other Names:
|
| Placebo Comparator: Tanreqing capsule simulator 3 capsules per time, 3 times a day，7 days of treatment |
Drug: Tanreqing capsule simulator
3 capsules per time, 3 times a day
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Improvement of major symptoms of COVID-19 [8 days]
On day 0, 1, 2, 3, 4, 5, 6 and 7, subjects' conditions and symptoms were recorded, and they were divided into primary and secondary symptoms according to mild and ordinary symptoms of COVID-19. The total score was 15 points, and the total score < 3 was regarded as symptom disappearance.
Secondary Outcome Measures
- Ct values of N gene and ORF gene were detected by novel Coronavirus nucleic acid [8 days]
Nucleic acid tests were performed on days 0, 1, 2, 3, 4, 5, 6 and 7. Ct values of N gene and ORF gene detected by novel Coronavirus nucleic acid were determined by fluorescence quantitative PCR. Negative: no Ct value or Ct value & GT; 40. Positive: CT value < 35.
- Turn to weight ratio [8 days]
The proportion of mild to normal type and normal to severe type. The condition of the subjects will be determined on day 0, 1, 2, 3, 4, 5, 6 and 7 respectively. The disease typing will be determined by Novel Coronavirus Diagnosis and Treatment Protocol for Pneumonia (Trial Version 9)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Those who conform to the diagnosis of novel coronavirus pneumonia according to the Novel Coronavirus Diagnosis and Treatment Protocol for Pneumonia (Trial Edition 9) and are clinically classified as mild or ordinary type;
-
Aged between 18 and 75, with no gender limitation;
-
Voluntarily accept the drug treatment and sign the informed consent.
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Jiangsu Famous Medical Technology Co., Ltd.
- Ruijin Hospital
Investigators
- Principal Investigator: Zhao Ren, Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine (North Hospital)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FM-P8-2022032501