Clinical trial NCT03704506: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Tonsillitis
Keywords: Reyanning mixture
efficacy
safety
randomized
double-blind
placebo-controlled
multicenter
antibiotics
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Beijing Chao Yang Hospital
name: Wangjing Hospital, China Academy of Chinese Medical Sciences
name: Beijing First Hospital of integrated Chinese and Western Medicine
First posted: 2018-10-12
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: recovery time
timeFrame: after 3 days of medication
measure: recovery time
timeFrame: after 7 days of medication
measure: recovery rate
timeFrame: after 3 days of medication
measure: recovery rate
timeFrame: after 7 days of medication
measure: antibiotic duration
timeFrame: after 7 days of medication
measure: antibiotic dosage
timeFrame: after 7 days of medication
Secondary outcomes:
measure: the vanish rate of single symptom/physical sign
timeFrame: after 3 days of medication
measure: the vanish rate of single symptom/physical sign
timeFrame: after 7 days of medication
measure: the ratio of WBC recovery
timeFrame: after 7 days of medication
measure: the time of fever relieving
timeFrame: after 7 days of medication
Other outcomes:
measure: To observe if Reyanning mixture causes liver function damage.
timeFrame: after 7 days of medication
measure: To observer if Reyanning mixture impacts renal function
timeFrame: after 7 days of medication
measure: To observer if Reyanning mixture causes renal damage
timeFrame: after 7 days of medication
Locations:
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Yanming Xie, BA
role: PRINCIPAL_INVESTIGATOR
References: