Clinical Trial Scheme of Tanreqing Capsules in the Treatment of COVID-19

Jiangsu Famous Medical Technology

Status and phase: Completed; Phase 3

Conditions: Novel Coronavirus Pneumonia

Treatments: Drug: Tanreqing capsule simulator; Drug: Tanreqing capsule

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05305456

FM-P8-2022032501

Details and patient eligibility

About

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.

Full 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.

Enrollment: 480 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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；
2. Aged greater than 18, with no gender limitation;
3. Symptom score greater than or equal 3 points;
4. Voluntarily accept the drug treatment and sign the informed consent.

Exclusion criteria

1. Patients with severe primary respiratory diseases or other pathogenic microbial pneumonia that needs to be differentiated from COVID-19;
2. immune deficiency disease, or use of immunosuppressants or glucocorticoids in the last 3 months;
3. pregnant and lactating women;
4. People with allergic constitution (allergic to more than two drugs or food or known allergic to the drug used in this study);
5. mentally ill persons or persons without self-awareness;
6. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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480 participants in 2 patient groups, including a placebo group

Tanreqing capsule

Experimental group

Description:

3 capsules per time, 3 times a day，7 days of treatment

Treatment:

Drug: Tanreqing capsule

Tanreqing capsule simulator

Placebo Comparator group

Description:

3 capsules per time, 3 times a day，7 days of treatment

Treatment:

Drug: Tanreqing capsule simulator