A Clinical Study of Treating Influenza With Liugan Shuangjie Heji
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- time from the medicine intake to 0.5℃ drop of body temperature
研究概览
简要总结
This prospective randomized controlled trial studies the efficacy and safety of treating influenza with the reconciling exterior and interior therapy. A total of 300 cases of seasonal flu in Beijing is to be collected, and divided into one treatment group and two control groups. Patients in the treatment group will receive Liugan Shuangjie Heji, while patients in control groups will receive Shufeng Jiedu Capsule and Oseltamivir Phosphate Capsule respectively, for a course of 5 days. The study assesses the efficacy and safety of treating influenza with the reconciling therapy based on the following outcome measures: the time it takes from the medicine intake to 0.5℃ drop of body temperature, and the time it takes for the body temperature to return to normal.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The disease in flu season of flu, in line with the western medicine clinical diagnostic criteria for influenza;
- •All influenza patients with TCM syndrome differentiation for the table is cold in the exterior and heat in the interior;
- •The course of the disease within 48 hours, the axillary temperature is 38.0 degree or higher;
- •Aged between 18 to 65 years;
- •Voluntary and signed informed consent.
排除标准
- •The first time to see a doctor Have used traditional Chinese medicine, or antiviral drugs;
- •Routine blood WBC is greater than the upper limit of normal;
- •Chest X-ray examination with inflammatory exudation images;
- •With cardiovascular, liver, kidney and hematopoietic system such as severe primary disease, immunodeficiency disease, cancer, mental illness, without self-knowledge, liver and kidney function significantly abnormal liver meritorious service is more than 1.5 times higher than normal;
- •Pregnancy, nursing mothers, and allergic constitution;
- •Participated in clinical subjects for nearly three months.
研究组 & 干预措施
Liugan Shuangjie Heji Group
Liugan Shuangjie Heji, take orally, 4 times a day, 100 ml each time (i.e. two doses per day), for a course of five days.
干预措施: Liugan Shuangjie Heji (Drug)
Shufeng Jiedu Capsule Group
Shufeng Jiedu Capsule, take orally, 3 times a day, 4 capsules each time, for a course of five days.
干预措施: Shufeng Jiedu Capsule (Drug)
Oseltamivir Phosphate Capsule Group
Oseltamivir Phosphate Capsule, take orally, 2 times a day, 75 mg each time, for a course of five days.
干预措施: Oseltamivir Phosphate Capsule (Drug)
结局指标
主要结局
time from the medicine intake to 0.5℃ drop of body temperature
时间窗: five days
time for the body temperature to return to normal
时间窗: five days
次要结局
未报告次要终点