Registration of the Study of Reyanning Mixture
Primary Purpose
Acute Tonsillitis
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Reyanning mixture
amoxil capsule
Reyanning mixture simulator
amoxil capsule simulator
Sponsored by
About this trial
This is an interventional treatment trial for Acute Tonsillitis focused on measuring Reyanning mixture, efficacy, safety, randomized, double-blind, placebo-controlled, multicenter, antibiotics
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
treatment group 1
treatment group 2
control group
Arm Description
Reyanning mixture+amoxil capsule simulator
Reyanning mixture +amoxil capsule
Reyanning mixture simulator +amoxil capsule
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
antibiotic duration
The duration of antibiotic will be observed.
antibiotic dosage
The dosage of antibiotic will be observed.
Secondary Outcome Measures
the vanish rate of single symptom/physical sign
The single symptom/physical sign include tonsil redness, pharyngeal pain, and fever.
the vanish rate of single symptom/physical sign
The single symptom/physical sign include tonsil redness, pharyngeal pain, and fever.
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.
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.
Full Information
NCT ID
NCT03704506
First Posted
October 7, 2018
Last Updated
October 10, 2018
Sponsor
China Academy of Chinese Medical Sciences
Collaborators
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Beijing Chao Yang Hospital, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing First Hospital of integrated Chinese and Western Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03704506
Brief Title
Registration of the Study of Reyanning Mixture
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 22, 2018 (Anticipated)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Academy of Chinese Medical Sciences
Collaborators
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Beijing Chao Yang Hospital, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing First Hospital of integrated Chinese and Western Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Tonsillitis
Keywords
Reyanning mixture, efficacy, safety, randomized, double-blind, placebo-controlled, multicenter, antibiotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group 1
Arm Type
Experimental
Arm Description
Reyanning mixture+amoxil capsule simulator
Arm Title
treatment group 2
Arm Type
Experimental
Arm Description
Reyanning mixture +amoxil capsule
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Reyanning mixture simulator +amoxil capsule
Intervention Type
Drug
Intervention Name(s)
Reyanning mixture
Other Intervention Name(s)
Reyanning
Intervention Description
Reyanning mixture , 20ml by mouth , 3 times per day for 7 days
Intervention Type
Drug
Intervention Name(s)
amoxil capsule
Other Intervention Name(s)
amoxicillin
Intervention Description
amoxil capsule , 0.5g by mouth , 3 times per day for 7 days
Intervention Type
Drug
Intervention Name(s)
Reyanning mixture simulator
Other Intervention Name(s)
Reyanning simulator
Intervention Description
Reyanning mixture simulator , 20ml by mouth , 3 times per day for 7 days
Intervention Type
Drug
Intervention Name(s)
amoxil capsule simulator
Other Intervention Name(s)
amoxicillin simulator
Intervention Description
amoxil capsule simulator , 0.5g by mouth , 3 times per day for 7 days
Primary Outcome Measure Information:
Title
recovery time
Description
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
Title
recovery time
Description
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
Title
recovery rate
Description
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
Title
recovery rate
Description
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
Title
antibiotic duration
Description
The duration of antibiotic will be observed.
Time Frame
after 7 days of medication
Title
antibiotic dosage
Description
The dosage of antibiotic will be observed.
Time Frame
after 7 days of medication
Secondary Outcome Measure Information:
Title
the vanish rate of single symptom/physical sign
Description
The single symptom/physical sign include tonsil redness, pharyngeal pain, and fever.
Time Frame
after 3 days of medication
Title
the vanish rate of single symptom/physical sign
Description
The single symptom/physical sign include tonsil redness, pharyngeal pain, and fever.
Time Frame
after 7 days of medication
Title
the ratio of WBC recovery
Description
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
Title
the time of fever relieving
Description
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
Other Pre-specified Outcome Measures:
Title
To observe if Reyanning mixture causes liver function damage.
Description
to assess the liver function indicators
Time Frame
after 7 days of medication
Title
To observer if Reyanning mixture impacts renal function
Description
to assess the renal function indicators ,including serum creatinine(Cr) and glomerular filtration rate( eGFR)
Time Frame
after 7 days of medication
Title
To observer if Reyanning mixture causes renal damage
Description
to assess the urinalysis indicators
Time Frame
after 7 days of medication
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanming Xie, BA
Phone
86-13911112416
Email
ktzu2018@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lianxin Wang, Doctor
Phone
86-13521781839
Email
wlxing@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanming Xie, BA
Organizational Affiliation
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Registration of the Study of Reyanning Mixture
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