Registration of the Study of Reyanning Mixture

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.

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.

Study Overview

• Status: Unknown
• Conditions: Acute Tonsillitis
• Intervention / Treatment: Drug: Reyanning mixture; Drug: amoxil capsule simulator; Drug: amoxil capsule; Drug: Reyanning mixture simulator

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 Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To observe if Reyanning mixture causes liver function damage.	to assess the liver function indicators	after 7 days of medication
To observer if Reyanning mixture impacts renal function	to assess the renal function indicators ,including serum creatinine(Cr) and glomerular filtration rate( eGFR)	after 7 days of medication
To observer if Reyanning mixture causes renal damage	to assess the urinalysis indicators	after 7 days of medication

Collaborators and Investigators

• Sponsor: China Academy of Chinese Medical Sciences
• Collaborators: Beijing Chao Yang Hospital; The First Affiliated Hospital of Henan University of Traditional Chinese Medicine; Wangjing Hospital, China Academy of Chinese Medical Sciences; Beijing First Hospital of integrated Chinese and Western Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): October 22, 2018
• Primary Completion (Anticipated): June 30, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: October 7, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (Actual): October 12, 2018

Study Record Updates

• Last Update Posted (Actual): October 12, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: safety; efficacy; multicenter; antibiotics; randomized; placebo-controlled; double-blind; Reyanning mixture
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Tonsillitis; Anti-Infective Agents; Anti-Bacterial Agents; Amoxicillin
• Other Study ID Numbers: Reyanning mixture

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No