Registration of the Study of Reyanning Mixture
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
| 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:
Drug: amoxil capsule simulator
amoxil capsule simulator , 0.5g by mouth , 3 times per day for 7 days
Other Names:
|
| 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:
Drug: amoxil capsule
amoxil capsule , 0.5g by mouth , 3 times per day for 7 days
Other Names:
|
| 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:
Drug: Reyanning mixture simulator
Reyanning mixture simulator , 20ml by mouth , 3 times per day for 7 days
Other Names:
|
Outcome Measures
Primary Outcome Measures
- recovery time [after 3 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 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 3 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.
- 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 duration [after 7 days of medication]
The duration of antibiotic will be observed.
- antibiotic dosage [after 7 days of medication]
The dosage of antibiotic will be observed.
Secondary Outcome Measures
- the vanish rate of single symptom/physical sign [after 3 days of medication]
The single symptom/physical sign include tonsil redness, pharyngeal pain, and fever.
- 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.
Other Outcome Measures
- To observe if Reyanning mixture causes liver function damage. [after 7 days of medication]
to assess the liver function indicators
- To observer if Reyanning mixture impacts renal function [after 7 days of medication]
to assess the renal function indicators ,including serum creatinine(Cr) and glomerular filtration rate( eGFR)
- To observer if Reyanning mixture causes renal damage [after 7 days of medication]
to assess the urinalysis indicators
Eligibility Criteria
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;
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course of disease within 72 hours;
-
sign informed consent.
Exclusion Criteria:
-
common cold,influenza, acute laryngopharyngitis, pharyngeal diphtheria, wensang's isthmitis.
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complicated with acute tracheobronchitis,pneumonia,rheumatic fever, acute glomerulonephritis or rheumatic heart disease.
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complicated with severe angiocardiopathy, cerebrovascular disease, hemopoietic system disease or psychopath.
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liver or kidney function is abnormal(ALT>1.5 times upper limit of normal; Cr>upper limit of normal); diabetic.
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WBC<10×109/L and neutrophilic granulocyte percentage<75%;or WBC ≥20×109/L;
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gestational, lactating women or who planning to get pregnant within half a year.
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already accept similar traditional Chinese medicine or antibiotic within 48 hours before registered.
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joining other clinical trials or allergic to any drug in this trials.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- China Academy of Chinese Medical Sciences
- 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
Investigators
- Principal Investigator: Yanming Xie, BA, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Reyanning mixture