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.
1 other identifier
interventional
144
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2018
CompletedFirst Posted
Study publicly available on registry
October 12, 2018
CompletedStudy Start
First participant enrolled
October 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedOctober 12, 2018
October 1, 2018
8 months
October 7, 2018
October 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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 Outcomes (4)
the vanish rate of single symptom/physical sign
after 3 days of medication
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
Other Outcomes (3)
To observe if Reyanning mixture causes liver function damage.
after 7 days of medication
To observer if Reyanning mixture impacts renal function
after 7 days of medication
To observer if Reyanning mixture causes renal damage
after 7 days of medication
Study Arms (3)
treatment group 1
EXPERIMENTALReyanning mixture+amoxil capsule simulator
treatment group 2
EXPERIMENTALReyanning mixture +amoxil capsule
control group
ACTIVE COMPARATORReyanning mixture simulator +amoxil capsule
Interventions
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
amoxil capsule simulator , 0.5g by mouth , 3 times per day for 7 days
Eligibility Criteria
You may qualify if:
- 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;
- years≤age≤65 years;
- course of disease within 72 hours;
- sign informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- China Academy of Chinese Medical Scienceslead
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicinecollaborator
- Beijing Chao Yang Hospitalcollaborator
- Wangjing Hospital, China Academy of Chinese Medical Sciencescollaborator
- Beijing First Hospital of integrated Chinese and Western Medicinecollaborator
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yanming Xie, BA
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy director
Study Record Dates
First Submitted
October 7, 2018
First Posted
October 12, 2018
Study Start
October 22, 2018
Primary Completion
June 30, 2019
Study Completion
December 31, 2019
Last Updated
October 12, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share