Registration of the Study of Reyanning Mixture

Phase 4

• Conditions: Acute Tonsillitis
• Interventions: Drug: Reyanning mixture; Drug: amoxil capsule; Drug: amoxil capsule simulator; Drug: Reyanning mixture simulator

• Registration Number: NCT03704506
• Lead Sponsor: China Academy of Chinese Medical Sciences

Brief Summary

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

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 Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-07
• Study First Submitted QC: 2018-10-10
• Last Update Submitted: 2018-10-10
• Study First Posted: 2018-10-12
• Last Update Posted: 2018-10-12
• Study Start: 2018-10-22
• Primary Completion: 2019-06-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

1. Meet the diagnostic criteria of acute tonsillitis;
2. Meet the traditional Chinese medicine symptom diagnostic criteria of external wind-heat type and excessive heat in the lung and stomach type;
3. 18 years≤age≤65 years;
4. course of disease within 72 hours;
5. sign informed consent.

Read More

Exclusion Criteria

1. common cold,influenza, acute laryngopharyngitis, pharyngeal diphtheria, wensang's isthmitis.
2. complicated with acute tracheobronchitis,pneumonia,rheumatic fever, acute glomerulonephritis or rheumatic heart disease.
3. complicated with severe angiocardiopathy, cerebrovascular disease, hemopoietic system disease or psychopath.
4. liver or kidney function is abnormal(ALT>1.5 times upper limit of normal; Cr>upper limit of normal); diabetic.
5. WBC<10×109/L and neutrophilic granulocyte percentage<75%;or WBC ≥20×109/L;
6. gestational, lactating women or who planning to get pregnant within half a year.
7. already accept similar traditional Chinese medicine or antibiotic within 48 hours before registered.
8. joining other clinical trials or allergic to any drug in this trials.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment group 2	amoxil capsule	Reyanning mixture +amoxil capsule
treatment group 1	Reyanning mixture	Reyanning mixture+amoxil capsule simulator
control group	amoxil capsule	Reyanning mixture simulator +amoxil capsule
treatment group 1	amoxil capsule simulator	Reyanning mixture+amoxil capsule simulator
treatment group 2	Reyanning mixture	Reyanning mixture +amoxil capsule
control group	Reyanning mixture simulator	Reyanning mixture simulator +amoxil capsule

Primary Outcome Measures

Name	Time	Method
recovery time	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	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	after 7 days of medication	The dosage of antibiotic will be observed.
antibiotic duration	after 7 days of medication	The duration of antibiotic will be observed.

Secondary Outcome Measures

Name	Time	Method
the vanish rate of single symptom/physical sign	after 7 days of medication	The single symptom/physical sign include tonsil redness, pharyngeal pain, and fever.
the ratio of WBC recovery	after 7 days of medication	The ratio of WBC recovery refers to the percentage of white blood cell count which return to normal range after 7 days of medication.
the time of fever relieving	after 7 days of medication	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.