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Huang-long Zhi-xiao Granule Improves the Control Rate of Chronic Persistent of Asthma

Primary Purpose

Asthma Chronic

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Huang-long Zhi-xiao Granule
Huang-long Zhi-xiao Granule placebo
Sponsored by
Henan University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma Chronic focused on measuring Huang-long Zhi-xiao Granule, Chronic persistent of asthma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients who meet the diagnostic criteria for chronic persistent bronchial asthma It meets the TCM differentiation standards for wheezing and hot wheezing Asthma Control Test (ACT) questionnaire score<20 score The severity of disease is graded from mild to moderately persistent Patients who have not been treated with anti-asthmatic drugs for 2 weeks prior to dosing or who have been treated with ICS or ICS+LABA for 4 weeks or more prior to dosing and who have the same type and dose of the drug Age form 18-80 years old Have not participated in other clinical studies within 1 month prior to enrollment Voluntarily participate in the study and sign an informed consent form Exclusion Criteria: Patients with special types of refractory asthma, critical asthma, occupational asthma, seasonal asthma, atypical asthma or tuberculosis, pulmonary interstitial fibrosis, thoracic malformation, chronic obstructive pulmonary disease, bronchiectasis, cystic pulmonary fibrosis, allergic bronchopulmonary aspergillosis, allergic granulomatous vasculitis, infectious, restrictive lung disease and other airflow obstructive pulmonary diseases Patients with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina, acute myocardial infarction, cardiac function grade 3 and above, stroke, cerebral hemorrhage, etc.) Glutamate aminotransferase (ALT), aspartate aminotransferase (AST) > 1.5 times the upper limit of normal value, blood creatinine (Cr) > upper limit of normal value Those who are allergic and allergic to the components of drugs in known test drugs Patients with bronchiectasis, tuberculosis, pulmonary embolism, or other serious respiratory conditions Combined with severe cognitive and psychiatric abnormalities Participants who are pregnant, lactating, and planning to become pregnant Those who are participating in other clinical trials within 1 month prior to enrollment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Huang-long Zhi-xiao Granule

    Huang-long Zhi-xiao Granule placebo

    Arm Description

    Huang-long Zhi-xiao Granule, Honey ephedra 6g, shot dried 10g, earth dragon 10g, Ganoderma lucidum 20g, Qianhu 12g, perilla seed 10g, Zhejiang fritillary 9g, soaphorn thorn 9g, scorched mulberry white peel 20g, fried white nuts 10g, fructus nume 10g, licorice 6g.

    The Huang-long Zhi-xiao Granule placebo is prepared by adding 5% of the drug on the basis of dextrin and bitter agent, and its appearance, weight, color and smell are consistent with Chinese medicine granules.

    Outcomes

    Primary Outcome Measures

    Asthma control tests(CAT)
    CAT will be used to evaluate quality of life. A total score of 0-40 will be given with a higher score indicating a worse condition.
    Frequencies of acute attacks
    It will be assessed by frequencies of asthma-related hospitalizations.The patient's disease progression was recorded by recording the number of acute attacks at each time point, as well as the specific condition at the time of the attack.

    Secondary Outcome Measures

    Asthma exacerbation severity and hospitalization rate
    Worsening lung function during asthma attacks is characterized by decreased expiratory flow, and the severity of the exacerbation can be graded by the patient's symptoms, lung function, and arterial blood gas analysis.According to the frequency of daytime and nighttime asthma attacks and pulmonary function test results, the patients were divided into 4 grades, namely: 1 intermittent attack; 2 mild persistent; 3 moderate persistent and 4 severe persistent.The severity of the asthma attack was assessed using a rating scale
    Change in severity of chronic persistent disease
    Although the patient does not have an acute attack of asthma, there are still symptoms such as wheezing, cough, chest tightness and other symptoms with different frequency and degrees for a long time, which may be accompanied by decreased pulmonary ventilation function. The severity of chronic persistent asthma can be classified into four levels: intermittent, mildly persistent, moderately persistent, and severely persistent, according to the frequency of daytime and nighttime asthma symptoms and the results of pulmonary function tests.The severity of the asthma attack was assessed using a rating scale
    The dose used by glucocorticoids
    Corticosteroids are the drug of choice for long-term asthma treatment. The vast majority of patients with chronic persistent asthma are well controlled by inhaling low-dose corticosteroids (equivalent to 400 micrograms of budesonide per day).
    Rapid-acting beta2 agonists use drugs and doses
    Beta2 agonists are asthma drugs that stimulate beta2 receptors distributed on airway smooth muscle to produce bronchodilating effects. These drugs are bronchodilators and are the drugs of choice for acute asthma attacks (airway spasm), which can quickly improve symptoms such as dyspnea, cough, etc. If given by inhalation, salbutamol 100-200mcg or terbutaline 250-500mcg at a time and repeat every 20 minutes if necessary,
    Score for clinical signs and symptoms
    Formulate with reference to the "Guidelines for Clinical Research of New Chinese Medicines"Clinical scoring is weighted or assigned according to some of the main symptoms, signs, physiological parameters of patients, etc., so as to quantitatively evaluate the severity of the disease.The higher the score, the worse the state.
    Pulmonary function
    Pulmonary function tests are an important part of the assessment of asthma and use objective indicators of lung function to monitor asthma.Routine pulmonary ventilation tests should be performed in all patients with clinically suspected asthma, and bronchodilator tests may be performed if ventilatory function suggests an obstructive change in ventilation. If the diastolic test is positive, the diagnosis of asthma can be established combined with clinical history, if the diastolic test is negative and FEV1 & GT. 70% predicted value, the conditional unit can do bronchial provocation test.
    Exhaled nitric oxide
    Asthma Control Questionnaire (ACQ)
    The content of ACQ involves the following aspects: asthma-related, symptoms, the use of first-aid drugs, the impact on daily life and lung function test results.The higher the score, the worse the state.
    Asthma Quality of Life Score (AQLQ) score
    The asthma quality of life scale (5-point scale-RRB- consists of 35 items, including activity limitation (1-12) , asthma symptoms (13-20) , psychological status (22-26) , response to stimuli (27-31) , concern for one's own health (32-35) . On a 5-point scale, 1 is the worst and 5 is the best.
    Sputum detection indicators
    ①Induced sputum inflammatory phenotype: the inflammatory phenotype was classified into eosinophilic asthma, neutrophil asthma, paucigranulocytic asthma and mixed granulocytic asthma according to the detection of Eos in sputum②Eosinophil granulocyte cationic protein(EPC)③Inflammatory factors: IL-4, IL-5, Il-13, IL-25④Mucin MUC5AC.

    Full Information

    First Posted
    February 3, 2023
    Last Updated
    April 23, 2023
    Sponsor
    Henan University of Traditional Chinese Medicine
    Collaborators
    The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, The Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05841901
    Brief Title
    Huang-long Zhi-xiao Granule Improves the Control Rate of Chronic Persistent of Asthma
    Official Title
    Evaluation of the Efficacy and Mechanism of Action of Huang-long Zhi-xiao Granule to Improve the Control Rate of Chronic Persistent of Asthma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    February 1, 2024 (Anticipated)
    Study Completion Date
    December 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Henan University of Traditional Chinese Medicine
    Collaborators
    The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, The Third Affiliated Hospital of Henan University of Traditional Chinese 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 goal of this observational study is to test the Evaluation of the efficacy and mechanism of action about Huang-long Zhi-xiao Granule to improve the control rate of Asthma chronic duration. The main questions it aims to answer are: [Relying on the top-level experimental design, scientifically evaluated the efficacy and safety of Huang-long Zhi-xiao Granule in patients with chronic asthma (hot asthma), and provided evidence support for the clinical application of Classical Prescriptions.] [Through the retained sample to test Asthma-related inflammatory indicators, immunoglobulins, T cell subsets, etc. To investigate the mechanism of action of Huang-long Zhi-xiao Granule in patients with chronic duration of asthma (hot asthma).]
    Detailed Description
    Bronchial asthma attacks are erratic and difficult to heal, which seriously affects the quality of life of patients, and their physical and mental health is also seriously affected by asthma. This study will conduct clinical observations in patients with chronic persistence (hot wheezing) of bronchial asthma, scientifically evaluate the efficacy and safety of Huanglong Anti-Wheezing in patients with asthma chronic duration (hot wheezing), and provide evidence support for the clinical application of Huanglong Anti-Wheezing Formula.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma Chronic
    Keywords
    Huang-long Zhi-xiao Granule, Chronic persistent of asthma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    224 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Huang-long Zhi-xiao Granule
    Arm Type
    Experimental
    Arm Description
    Huang-long Zhi-xiao Granule, Honey ephedra 6g, shot dried 10g, earth dragon 10g, Ganoderma lucidum 20g, Qianhu 12g, perilla seed 10g, Zhejiang fritillary 9g, soaphorn thorn 9g, scorched mulberry white peel 20g, fried white nuts 10g, fructus nume 10g, licorice 6g.
    Arm Title
    Huang-long Zhi-xiao Granule placebo
    Arm Type
    Placebo Comparator
    Arm Description
    The Huang-long Zhi-xiao Granule placebo is prepared by adding 5% of the drug on the basis of dextrin and bitter agent, and its appearance, weight, color and smell are consistent with Chinese medicine granules.
    Intervention Type
    Drug
    Intervention Name(s)
    Huang-long Zhi-xiao Granule
    Intervention Description
    The experimental group was given Huang-long Zhi-xiao Granule.1 dose per day, oral in 2 divided doses, 1 course every 4 weeks, for a total of 8 weeks of treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    Huang-long Zhi-xiao Granule placebo
    Intervention Description
    The toncral group was given placebo Huang-long Zhi-xiao Granule.The course of treatment was the same as that of the experimental group.
    Primary Outcome Measure Information:
    Title
    Asthma control tests(CAT)
    Description
    CAT will be used to evaluate quality of life. A total score of 0-40 will be given with a higher score indicating a worse condition.
    Time Frame
    Change from baseline CAT scores at week 4, 8, 21, 34,47 and 52.
    Title
    Frequencies of acute attacks
    Description
    It will be assessed by frequencies of asthma-related hospitalizations.The patient's disease progression was recorded by recording the number of acute attacks at each time point, as well as the specific condition at the time of the attack.
    Time Frame
    Up to week 52.
    Secondary Outcome Measure Information:
    Title
    Asthma exacerbation severity and hospitalization rate
    Description
    Worsening lung function during asthma attacks is characterized by decreased expiratory flow, and the severity of the exacerbation can be graded by the patient's symptoms, lung function, and arterial blood gas analysis.According to the frequency of daytime and nighttime asthma attacks and pulmonary function test results, the patients were divided into 4 grades, namely: 1 intermittent attack; 2 mild persistent; 3 moderate persistent and 4 severe persistent.The severity of the asthma attack was assessed using a rating scale
    Time Frame
    Week0(before treatment),week4、week8、week21、week34、week47and week52.
    Title
    Change in severity of chronic persistent disease
    Description
    Although the patient does not have an acute attack of asthma, there are still symptoms such as wheezing, cough, chest tightness and other symptoms with different frequency and degrees for a long time, which may be accompanied by decreased pulmonary ventilation function. The severity of chronic persistent asthma can be classified into four levels: intermittent, mildly persistent, moderately persistent, and severely persistent, according to the frequency of daytime and nighttime asthma symptoms and the results of pulmonary function tests.The severity of the asthma attack was assessed using a rating scale
    Time Frame
    Week0(before treatment),week4、week8、week21、week34、week47and week52.
    Title
    The dose used by glucocorticoids
    Description
    Corticosteroids are the drug of choice for long-term asthma treatment. The vast majority of patients with chronic persistent asthma are well controlled by inhaling low-dose corticosteroids (equivalent to 400 micrograms of budesonide per day).
    Time Frame
    Week0(before treatment),week4、week8、week21、week34、week47 and week52.
    Title
    Rapid-acting beta2 agonists use drugs and doses
    Description
    Beta2 agonists are asthma drugs that stimulate beta2 receptors distributed on airway smooth muscle to produce bronchodilating effects. These drugs are bronchodilators and are the drugs of choice for acute asthma attacks (airway spasm), which can quickly improve symptoms such as dyspnea, cough, etc. If given by inhalation, salbutamol 100-200mcg or terbutaline 250-500mcg at a time and repeat every 20 minutes if necessary,
    Time Frame
    Week0(before treatment),week8 and after follow-up(week52)
    Title
    Score for clinical signs and symptoms
    Description
    Formulate with reference to the "Guidelines for Clinical Research of New Chinese Medicines"Clinical scoring is weighted or assigned according to some of the main symptoms, signs, physiological parameters of patients, etc., so as to quantitatively evaluate the severity of the disease.The higher the score, the worse the state.
    Time Frame
    Week0(before treatment),week8 and after follow-up(week52)
    Title
    Pulmonary function
    Description
    Pulmonary function tests are an important part of the assessment of asthma and use objective indicators of lung function to monitor asthma.Routine pulmonary ventilation tests should be performed in all patients with clinically suspected asthma, and bronchodilator tests may be performed if ventilatory function suggests an obstructive change in ventilation. If the diastolic test is positive, the diagnosis of asthma can be established combined with clinical history, if the diastolic test is negative and FEV1 & GT. 70% predicted value, the conditional unit can do bronchial provocation test.
    Time Frame
    Week0(before treatment),week4、week8、week21、week34、week47and week52.
    Title
    Exhaled nitric oxide
    Time Frame
    Week0(before treatment),week4、week8、week21、week34、week47and week52.
    Title
    Asthma Control Questionnaire (ACQ)
    Description
    The content of ACQ involves the following aspects: asthma-related, symptoms, the use of first-aid drugs, the impact on daily life and lung function test results.The higher the score, the worse the state.
    Time Frame
    Week0(before treatment),week8 and after follow-up(week52)
    Title
    Asthma Quality of Life Score (AQLQ) score
    Description
    The asthma quality of life scale (5-point scale-RRB- consists of 35 items, including activity limitation (1-12) , asthma symptoms (13-20) , psychological status (22-26) , response to stimuli (27-31) , concern for one's own health (32-35) . On a 5-point scale, 1 is the worst and 5 is the best.
    Time Frame
    Week0(before treatment),week8 and after follow-up(week52)
    Title
    Sputum detection indicators
    Description
    ①Induced sputum inflammatory phenotype: the inflammatory phenotype was classified into eosinophilic asthma, neutrophil asthma, paucigranulocytic asthma and mixed granulocytic asthma according to the detection of Eos in sputum②Eosinophil granulocyte cationic protein(EPC)③Inflammatory factors: IL-4, IL-5, Il-13, IL-25④Mucin MUC5AC.
    Time Frame
    Week0(before treatment), week 8,after follow-up(week52)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who meet the diagnostic criteria for chronic persistent bronchial asthma It meets the TCM differentiation standards for wheezing and hot wheezing Asthma Control Test (ACT) questionnaire score<20 score The severity of disease is graded from mild to moderately persistent Patients who have not been treated with anti-asthmatic drugs for 2 weeks prior to dosing or who have been treated with ICS or ICS+LABA for 4 weeks or more prior to dosing and who have the same type and dose of the drug Age form 18-80 years old Have not participated in other clinical studies within 1 month prior to enrollment Voluntarily participate in the study and sign an informed consent form Exclusion Criteria: Patients with special types of refractory asthma, critical asthma, occupational asthma, seasonal asthma, atypical asthma or tuberculosis, pulmonary interstitial fibrosis, thoracic malformation, chronic obstructive pulmonary disease, bronchiectasis, cystic pulmonary fibrosis, allergic bronchopulmonary aspergillosis, allergic granulomatous vasculitis, infectious, restrictive lung disease and other airflow obstructive pulmonary diseases Patients with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina, acute myocardial infarction, cardiac function grade 3 and above, stroke, cerebral hemorrhage, etc.) Glutamate aminotransferase (ALT), aspartate aminotransferase (AST) > 1.5 times the upper limit of normal value, blood creatinine (Cr) > upper limit of normal value Those who are allergic and allergic to the components of drugs in known test drugs Patients with bronchiectasis, tuberculosis, pulmonary embolism, or other serious respiratory conditions Combined with severe cognitive and psychiatric abnormalities Participants who are pregnant, lactating, and planning to become pregnant Those who are participating in other clinical trials within 1 month prior to enrollment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Minghang Wang, MD
    Phone
    0371-66248624
    Email
    wmh107hn@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Minghang Wang, MD
    Organizational Affiliation
    Henan University of Traditonal Chinese Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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