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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
144
Reyanning mixture , 20ml by mouth , 3 times per day for 7 days
amoxil capsule , 0.5g by mouth , 3 times per day for 7 days
Reyanning mixture simulator , 20ml by mouth , 3 times per day for 7 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: after 7 days of medication
antibiotic duration
The duration of antibiotic will be observed.
Time frame: after 7 days of medication
antibiotic dosage
The dosage of antibiotic will be observed.
Time frame: after 7 days of medication
the vanish rate of single symptom/physical sign
The single symptom/physical sign include tonsil redness, pharyngeal pain, and fever.
Time frame: after 3 days of medication
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amoxil capsule simulator , 0.5g by mouth , 3 times per day for 7 days
the vanish rate of single symptom/physical sign
The single symptom/physical sign include tonsil redness, pharyngeal pain, and fever.
Time frame: 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.
Time frame: 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.
Time frame: after 7 days of medication