A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial of the Efficacy and Safety of Treating Acute Tonsillitis With Reyanning Mixture Alone/in Combination With Antibiotics.
试验速览
- 阶段
- 4 期
- 入组人数
- 144
- 主要终点
- recovery time
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of treating with acute tonsillitis using Reyanning mixture alone/in combination with antibiotics, and its function of reducing the use of antibiotics.
详细描述
In order to evaluate the efficacy,safety and the function of reducing the use of antibiotics of Reyanning mixture (a mixture of Chinese herbal medicine) in treating with acute tonsillitis, a randomized, double-blind, placebo-controlled, multicenter clinical trials will be established. According to the relevant regulations of the China Food and Drug Administration(CFDA), 144 cases need to be registered at least. The aim population is who suffering of acute tonsillitis from October 2018 to December 2019.These cases will be randomly divided into treatment group 1(Reyanning mixture +amoxil capsule simulator),treatment group 2(Reyanning mixture +amoxil capsule) and control group(Reyanning mixture simulator +amoxil capsule).Each group will be treated for 7 days and followed up for 3 times . The main indicators include the recovery time/rate and antibiotic duration/dosage. And the vanish rate of single symptom/physical sign, the ratio of white blood cell count(WBC) recovery, the time of fever will be observed as well.
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
- •Meet the diagnostic criteria of acute tonsillitis;
- •Meet the traditional Chinese medicine symptom diagnostic criteria of external wind-heat type and excessive heat in the lung and stomach type;
- •18 years≤age≤65 years;
- •course of disease within 72 hours;
- •sign informed consent.
排除标准
- •common cold,influenza, acute laryngopharyngitis, pharyngeal diphtheria, wensang's isthmitis.
- •complicated with acute tracheobronchitis,pneumonia,rheumatic fever, acute glomerulonephritis or rheumatic heart disease.
- •complicated with severe angiocardiopathy, cerebrovascular disease, hemopoietic system disease or psychopath.
- •liver or kidney function is abnormal(ALT>1.5 times upper limit of normal; Cr>upper limit of normal); diabetic.
- •WBC<10×109/L and neutrophilic granulocyte percentage<75%;or WBC ≥20×109/L;
- •gestational, lactating women or who planning to get pregnant within half a year.
- •already accept similar traditional Chinese medicine or antibiotic within 48 hours before registered.
- •joining other clinical trials or allergic to any drug in this trials.
研究组 & 干预措施
treatment group 1
Reyanning mixture+amoxil capsule simulator
干预措施: Reyanning mixture (Drug)
treatment group 1
Reyanning mixture+amoxil capsule simulator
干预措施: amoxil capsule simulator (Drug)
treatment group 2
Reyanning mixture +amoxil capsule
干预措施: Reyanning mixture (Drug)
treatment group 2
Reyanning mixture +amoxil capsule
干预措施: amoxil capsule (Drug)
control group
Reyanning mixture simulator +amoxil capsule
干预措施: amoxil capsule (Drug)
control group
Reyanning mixture simulator +amoxil capsule
干预措施: Reyanning mixture simulator (Drug)
结局指标
主要结局
recovery time
时间窗: after 7 days of medication
The recovery time will be observed. Recovery means that the main signs and symptoms score is zero, and body temperature is below 37.3 ℃ maintaining for at least 24 hours.
recovery rate
时间窗: after 7 days of medication
The recovery rate will be observed. Recovery means that the main signs and symptoms score is zero, and body temperature is below 37.3 ℃ maintaining for at least 24 hours.
antibiotic dosage
时间窗: after 7 days of medication
The dosage of antibiotic will be observed.
antibiotic duration
时间窗: after 7 days of medication
The duration of antibiotic will be observed.
次要结局
- the vanish rate of single symptom/physical sign(after 7 days of medication)
- the ratio of WBC recovery(after 7 days of medication)
- the time of fever relieving(after 7 days of medication)
研究者
Yanming Xie
Deputy director
China Academy of Chinese Medical Sciences