A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial of Tanreqing Capsule Efficacy and Safety in the Treatment of COVID-19 (Mild and Common Type)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- The time from the first dose to sustained clinical recovery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Tanreqing capsule
3 capsules per time, 3 times a day，7 days of treatment
干预措施: Tanreqing capsule (Drug)
Tanreqing capsule simulator
3 capsules per time, 3 times a day，7 days of treatment
干预措施: Tanreqing capsule simulator (Drug)
结局指标
主要结局
The time from the first dose to sustained clinical recovery
时间窗: 8 days
Symptom domains and minors disappear completely within 7 days treatment period after randomization, and maintain it for 2 days without recurrence and the disease don't aggravate
次要结局
- Novel coronavirus N and ORF gene changes(8 days)
- The time from the first dose/first testing positive of virus to testing sustained negative of virus within 7 days treatment period after randomization(8 days)
- Effective rate of wind heat attacking lung syndrome(8 days)
- Duration of disappearance of main symptoms of wind heat attacking lung syndrome(8 days)
- Weight conversion rate (ratio of light type to ordinary type and ordinary type to heavy type)(90 days)