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Registration of the Study of Reyanning Mixture

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ClinicalTrials.gov Identifier: NCT03704506
Recruitment Status : Not yet recruiting
First Posted : October 12, 2018
Last Update Posted : October 12, 2018
Sponsor:
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
Information provided by (Responsible Party):
Yanming Xie, China Academy of Chinese Medical Sciences

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
Acute Tonsillitis Drug: Reyanning mixture Drug: amoxil capsule Drug: Reyanning mixture simulator Drug: amoxil capsule simulator 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Estimated Study Start Date : October 22, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

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 Name: Reyanning

Drug: amoxil capsule simulator
amoxil capsule simulator , 0.5g by mouth , 3 times per day for 7 days
Other Name: amoxicillin simulator

Experimental: treatment group 2
Reyanning mixture +amoxil capsule
Drug: Reyanning mixture
Reyanning mixture , 20ml by mouth , 3 times per day for 7 days
Other Name: Reyanning

Drug: amoxil capsule
amoxil capsule , 0.5g by mouth , 3 times per day for 7 days
Other Name: amoxicillin

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 Name: amoxicillin

Drug: Reyanning mixture simulator
Reyanning mixture simulator , 20ml by mouth , 3 times per day for 7 days
Other Name: Reyanning simulator




Primary Outcome Measures :
  1. recovery time [ Time Frame: 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.

  2. recovery time [ Time Frame: 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.

  3. recovery rate [ Time Frame: 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.

  4. recovery rate [ Time Frame: 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.

  5. antibiotic duration [ Time Frame: after 7 days of medication ]
    The duration of antibiotic will be observed.

  6. antibiotic dosage [ Time Frame: after 7 days of medication ]
    The dosage of antibiotic will be observed.


Secondary Outcome Measures :
  1. the vanish rate of single symptom/physical sign [ Time Frame: after 3 days of medication ]
    The single symptom/physical sign include tonsil redness, pharyngeal pain, and fever.

  2. the vanish rate of single symptom/physical sign [ Time Frame: after 7 days of medication ]
    The single symptom/physical sign include tonsil redness, pharyngeal pain, and fever.

  3. the ratio of WBC recovery [ Time Frame: 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.

  4. the time of fever relieving [ Time Frame: 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:
  1. To observe if Reyanning mixture causes liver function damage. [ Time Frame: after 7 days of medication ]
    to assess the liver function indicators

  2. To observer if Reyanning mixture impacts renal function [ Time Frame: after 7 days of medication ]
    to assess the renal function indicators ,including serum creatinine(Cr) and glomerular filtration rate( eGFR)

  3. To observer if Reyanning mixture causes renal damage [ Time Frame: after 7 days of medication ]
    to assess the urinalysis indicators



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03704506


Contacts
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Contact: Yanming Xie, BA 86-13911112416 ktzu2018@163.com
Contact: Lianxin Wang, Doctor 86-13521781839 wlxing@126.com

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
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Principal Investigator: Yanming Xie, BA Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

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Responsible Party: Yanming Xie, Deputy director, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03704506     History of Changes
Other Study ID Numbers: Reyanning mixture
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yanming Xie, China Academy of Chinese Medical Sciences:
Reyanning mixture
efficacy
safety
randomized
double-blind
placebo-controlled
multicenter
antibiotics
Additional relevant MeSH terms:
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Tonsillitis
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents