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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
China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

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

    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
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    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

    Learn more about this trial

    Registration of the Study of Reyanning Mixture

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