Registration of the Study of Reyanning Mixture

China Academy of Chinese Medical Sciences

Status and phase: Unknown; Phase 4

Conditions: Acute Tonsillitis

Treatments: Drug: Reyanning mixture simulator; Drug: amoxil capsule simulator; Drug: amoxil capsule; Drug: Reyanning mixture

Study type: Interventional

Funder types: Other

Identifiers

NCT03704506

Reyanning mixture

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

144 participants in 3 patient groups

treatment group 1

Experimental group

Description:

Reyanning mixture+amoxil capsule simulator

Treatment:

Drug: Reyanning mixture

Drug: amoxil capsule simulator

treatment group 2

Experimental group

Description:

Reyanning mixture +amoxil capsule

Treatment:

Drug: amoxil capsule

Drug: Reyanning mixture

control group

Active Comparator group

Description:

Reyanning mixture simulator +amoxil capsule

Treatment:

Drug: amoxil capsule

Drug: Reyanning mixture simulator