A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Clinical Study on the Efficacy and Safety of Reduning Injection in the Treatment of Chikungunya Fever
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Duration of symptoms
研究概览
简要总结
To evaluate the efficacy and safety of Reduning Injection in the treatment of chikungunya fever
详细描述
This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical study of the efficacy and safety of Reduning Injection in the treatment of Chikungunya fever. The purpose of this study is to evaluate the efficacy and safety of Reduning Injection in the treatment of Chikungunya fever. The study uses the IWRS system to randomize the study participants, adopts the double-blind method, selects placebo control, plans to be conducted simultaneously in multiple research centers across the country, plans to include 400 study participants, and randomly assigns them to the test drug group and the placebo group at a 1:1 ratio, with 200 participants in the test drug group.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Reduning treatment group
Redunign Injection, intravenous drip, 20 ml per dose, once a day
干预措施: Reduning injection (Drug)
placebo group
The simulant of Reduning Injection, for intravenous drip, 20 ml per time, once a day
干预措施: The simulant of Reduning Injection (Drug)
结局指标
主要结局
Duration of symptoms
时间窗: -1 day to 0 day, medication duration of 5 days ± 1 day, onset of disease 14 days ± 2 days after the onset, 90 days ± 3 days after the onset
The time from the first administration of the medication until all scores for the symptoms of chikungunya fever were 0 or 1 points (if the score was 1 before the medication, it must be reduced to 0), and this remained stable for 48 hours or more
次要结局
- Time for fever reduction to take effect(The subjects recorded these information in the "Subject Diary Card" during the period from -1 day to 0 day, 5 days ± 1 day after medication administration, and 14 days ± 2 days after the onset of the disease.)
- The change in the number of joint pain episodes compared to the baseline value(The researchers conducted evaluations on the study participants once each at -1 day to 0 day, 5 days ± 1 day after medication administration, and 14 days ± 2 days after the onset of the disease.)
- Recovery time of body temperature(The subjects recorded these information in the "Subject Diary Card" during the period from -1 day to 0 day, 5 days ± 1 day after medication administration, and 14 days ± 2 days after the onset of the disease.)
- Time for disappearance of individual symptoms(-1 day to 0 day, medication duration of 5 days ± 1 day, onset of disease 14 days ± 2 days after the onset, 90 days ± 3 days after the onset)
- The rate of disappearance of individual symptoms(-1 day to 0 day, medication duration of 5 days ± 1 day, onset of disease 14 days ± 2 days after the onset, 90 days ± 3 days after the onset)
- The incidence rate of complications (such as bleeding, hematoma, encephalitis, myelitis, etc.)(From -1 day to 0 day, and up to 90 days ± 3 days after the onset of the disease, the occurrence of complications by the subjects will be recorded by the researchers.)
- The usage situation of emergency medications(From -1 day to 0 day, within 5 days ± 1 day after medication administration, and 14 days ± 2 days after the onset of the disease.)
- The change in the integer VAS score for joint pain from baseline after 5 days of medication and 14 days after the onset of the disease(After taking the medicine for 5 days, 14 days after the onset of the disease)