NCT03089138Unknown2 期
Efficacy and Safety of Regan Tangjiang for Treating the Common Cold With Wind-heat Syndrome: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled Phase 2b Study
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 主要终点
- Time to fever relief
研究概览
简要总结
Efficacy and Safety of Regan Tangjiang for treating the common cold with wind-heat syndrome: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled Phase 2b Study
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of common cold according to Western Medicine，with symptoms onset and fever less than 24 hours prior to randomization；
- •After the onset of the disease, with the following symptoms: sore throat and axillary temperature between 38.5 and 38.9°C inclusive.
- •Diagnosis of wind-heat syndrome according to TCM；
- •Aged between 18 to 65 years；
- •Willingness to participate and to sign the informed consent form.
排除标准
- •Participants with Pneumonia, suppurative tonsillitis, acute tracheobronchitis, acute and chronic sinusitis, pulmonary tuberculosis and other diseases;
- •White blood cell count >11.0×109/L, or neutrophil percentage>75%;
- •Participants with liver function 1.5 times higher than the normal upper limit or serum creatinine higher than the normal upper limit;
- •Participants with severe primary diseases of cardiovascular, brain, lung, liver, kidney and hematopoietic system , such as viral hepatitis, hemophilia, diabetes, psychosis and so on;
- •Participants who had used other drugs to treat common cold after the onset of the disease, including antivirals, antibiotics and traditional Chinese medicine.
- •Women who are pregnant or breast-feeding;
- •Allergic condition (refer to history of allergy to two or more drugs or food) or allergy to the drug composition(s);
- •Participation in another clinical study of an investigational drug within 3 months
- •Participants who are not suitable for the trial decided by the researchers for any reason, such as pregnancy, frequently changes in work or living environments.
研究组 & 干预措施
Regan Tangjiang，Simulation Shufengjiere Capsules
Experimental
干预措施: Regan Tangjiang (Drug)
Simulation Regan Tangjiang，Shufengjiere Capsules
Active Comparator
干预措施: Regan Tangjiang (Drug)
Simulation Regan Tangjiang and Shufengjiere Capsules
Placebo Comparator
干预措施: Regan Tangjiang (Drug)
结局指标
主要结局
Time to fever relief
时间窗: day 1 to day 3
The median time from the first dosing to time when the body temperature drops by at least 0.5℃.In this study, all patients will be required to record their body temperature in the patient diary every 2 hours within the first 12 hours and every 4 hours during the following 12 hours. After that, it should be recorded four times at a fixed time every day.
次要结局
- Time to fever clearance(day 1 to day 3)
- Time to symptom disappearance(day 1 to day 3)
- Usage of emergency medicines(day 1 to day 3)
- Disappearance rate of symptoms(day 1 to day 3)
- Efficacy in TCM symptom and sign scores(day 1 to day 3)
研究者
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