Registration of the Study of Reyanning Mixture

NCT ID: NCT03704506

Last Updated: 2018-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-22

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Acute Tonsillitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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treatment group 1

Reyanning mixture+amoxil capsule simulator

Group Type EXPERIMENTAL

Reyanning mixture

Intervention Type DRUG

Reyanning mixture , 20ml by mouth , 3 times per day for 7 days

amoxil capsule simulator

Intervention Type DRUG

amoxil capsule simulator , 0.5g by mouth , 3 times per day for 7 days

treatment group 2

Reyanning mixture +amoxil capsule

Group Type EXPERIMENTAL

Reyanning mixture

Intervention Type DRUG

Reyanning mixture , 20ml by mouth , 3 times per day for 7 days

amoxil capsule

Intervention Type DRUG

amoxil capsule , 0.5g by mouth , 3 times per day for 7 days

control group

Reyanning mixture simulator +amoxil capsule

Group Type ACTIVE_COMPARATOR

amoxil capsule

Intervention Type DRUG

amoxil capsule , 0.5g by mouth , 3 times per day for 7 days

Reyanning mixture simulator

Intervention Type DRUG

Reyanning mixture simulator , 20ml by mouth , 3 times per day for 7 days

Interventions

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Reyanning mixture

Reyanning mixture , 20ml by mouth , 3 times per day for 7 days

Intervention Type DRUG

amoxil capsule

amoxil capsule , 0.5g by mouth , 3 times per day for 7 days

Intervention Type DRUG

Reyanning mixture simulator

Reyanning mixture simulator , 20ml by mouth , 3 times per day for 7 days

Intervention Type DRUG

amoxil capsule simulator

amoxil capsule simulator , 0.5g by mouth , 3 times per day for 7 days

Intervention Type DRUG

Other Intervention Names

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Reyanning amoxicillin Reyanning simulator amoxicillin simulator

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role collaborator

Wangjing Hospital, China Academy of Chinese Medical Sciences

OTHER

Sponsor Role collaborator

Beijing First Hospital of integrated Chinese and Western Medicine

OTHER

Sponsor Role collaborator

China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Yanming Xie

Deputy director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanming Xie, BA

Role: PRINCIPAL_INVESTIGATOR

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Central Contacts

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Yanming Xie, BA

Role: CONTACT

86-13911112416

Lianxin Wang, Doctor

Role: CONTACT

86-13521781839

Other Identifiers

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Reyanning mixture

Identifier Type: -

Identifier Source: org_study_id

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