Registration of the Study of Reyanning Mixture

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Acute Tonsillitis

Intervention / Treatment
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* Drug: Reyanning mixture
* Drug: amoxil capsule
* Drug: Reyanning mixture simulator
* Drug: amoxil capsule simulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group 1<br>Reyanning mixture+amoxil capsule simulator | Drug: Reyanning mixture<br>* Reyanning mixture , 20ml by mouth , 3 times per day for 7 days<br>* Other names: Reyanning;Drug: amoxil capsule simulator<br>* amoxil capsule simulator , 0.5g by mouth , 3 times per day for 7 days<br>* Other names: amoxicillin simulator;|
| Experimental: treatment group 2<br>Reyanning mixture +amoxil capsule | Drug: Reyanning mixture<br>* Reyanning mixture , 20ml by mouth , 3 times per day for 7 days<br>* Other names: Reyanning;Drug: amoxil capsule<br>* amoxil capsule , 0.5g by mouth , 3 times per day for 7 days<br>* Other names: amoxicillin;|
| Active Comparator: control group<br>Reyanning mixture simulator +amoxil capsule | Drug: amoxil capsule<br>* amoxil capsule , 0.5g by mouth , 3 times per day for 7 days<br>* Other names: amoxicillin;Drug: Reyanning mixture simulator<br>* Reyanning mixture simulator , 20ml by mouth , 3 times per day for 7 days<br>* Other names: Reyanning simulator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recovery time | 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. | after 3 days of medication | 
| recovery time | 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. | after 7 days of medication | 
| recovery rate | 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. | after 3 days of medication | 
| recovery rate | 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. | after 7 days of medication | 
| antibiotic duration | The duration of antibiotic will be observed. | after 7 days of medication | 
| antibiotic dosage | The dosage of antibiotic will be observed. | after 7 days of medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the vanish rate of single symptom/physical sign | The single symptom/physical sign include tonsil redness, pharyngeal pain, and fever. | after 3 days of medication | 
| the vanish rate of single symptom/physical sign | The single symptom/physical sign include tonsil redness, pharyngeal pain, and fever. | after 7 days of medication | 
| the ratio of WBC recovery | The ratio of WBC recovery refers to the percentage of white blood cell count which return to normal range after 7 days of medication. | after 7 days of medication | 
| the time of fever relieving | The time of fever relieving means that the duration from the first medication to the body temperature drops below 37.3℃ maintaining for at least 24 hours. | after 7 days of medication | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reyanning mixture, efficacy, safety, randomized, double-blind, placebo-controlled, multicenter, antibiotics