A Randomized Controlled Multicenter Clinical Study on the Effectiveness of Jinzhen Oral Liquid in Treating Children With Novel Coronavirus Infection
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- First negative time of COVID-19
研究概览
简要总结
Jinzhen oral liquid and Jinhuaqinggan Granules were used in the treatment and the control group for 14 days, respectively, to evaluate the effect of Jinzhen oral liquid in treating children with novel coronavirus infection.
详细描述
To evaluate the effect of Jinzhen oral liquid in treating children with novel coronavirus infection by shortening the time of first negative turn of virus, improving clinical symptoms and shortening hospital stay, and to observe the safety of Jinzhen oral liquid in clinical application.A total of 240 Patients aged 3 to 18 years old or asymptomatic infected persons who meet the diagnostic criteria for novel coronavirus infection in the COVID-19 Diagnosis and Treatment Protocol (Trial Version 9)were planned to be enrolled. Jinzhen oral liquid was used in the treatment group, and Jinhuaqinggan Granules was used in the control group, with 120 patients in each group. The subjects took the medication for 14 days (the medication could be stopped in advance if they reached the discharge criteria), and were followed up for 14 days after discontinuation. During the treatment period, the subjects' vital signs, chest imaging examination, novel coronavirus nucleic acid test, blood routine, urine routine, liver and kidney function, and condition and symptoms should be monitored on the follow-up day specified in the protocol.
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
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria of novel coronavirus infected patients in COVID-19 Diagnosis and Treatment Protocol (Trial Version 9);
- •Asymptomatic infection or clinical classification of mild or common type;
- •Aged from 3 to 18 years;
- •The informed consent process was in accordance with the regulations, and the legal guardian or the children (≥8 years old) signed the informed consent form.
排除标准
- •Meet the severe/critical early warning indicators;
- •Children who used proprietary Chinese medicine of the same type for more than 3 days before enrollment;
- •Children with diarrhea.
研究组 & 干预措施
treatment group
Jinzhen oral liquid(for 3 years old, 10 ml once, twice a day; for 4 to 7 years old, 10 ml a time, 3 times a day; for 8 to 18 years old, 15 ml a time, 3 times a day)
干预措施: Jinzhen oral liquid or Jinhuaqinggan granules (Drug)
control group
The usage and dosage of Jinhua Qinggan granules were determined by the researcher according to the patient's condition and recorded truthfully
干预措施: Jinzhen oral liquid or Jinhuaqinggan granules (Drug)
结局指标
主要结局
First negative time of COVID-19
时间窗: up to 6 months
First negative time of COVID-19
次要结局
- Clinical symptom disappearance rate/time(up to 6 months)
- The hospitalization time(up to 6 months)
- Incidence of conversion to severe/critical illness Incidence of conversion to severe/critical illness Incidence of conversion to severe/critical illness(up to 6 months)