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

Last updated: April 23, 2023
Sponsor: Henan University of Traditional Chinese Medicine
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Asthma

Treatment

Huang-long Zhi-xiao Granule placebo

Huang-long Zhi-xiao Granule

Clinical Study ID

NCT05841901
TCM for Asthma
  • Ages 18-80
  • All Genders

Study 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).]

Eligibility Criteria

Inclusion

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 todosing or who have been treated with ICS or ICS+LABA for 4 weeks or more prior todosing 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

Exclusion Criteria:

  • Patients with special types of refractory asthma, critical asthma, occupationalasthma, seasonal asthma, atypical asthma or tuberculosis, pulmonary interstitialfibrosis, thoracic malformation, chronic obstructive pulmonary disease,bronchiectasis, cystic pulmonary fibrosis, allergic bronchopulmonary aspergillosis,allergic granulomatous vasculitis, infectious, restrictive lung disease and otherairflow obstructive pulmonary diseases
  • Patients with severe cardiovascular and cerebrovascular diseases (malignantarrhythmia, unstable angina, acute myocardial infarction, cardiac function grade 3 andabove, stroke, cerebral hemorrhage, etc.)
  • Glutamate aminotransferase (ALT), aspartate aminotransferase (AST) > 1.5 times theupper 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 seriousrespiratory 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 toenrollment

Study Design

Total Participants: 224
Treatment Group(s): 2
Primary Treatment: Huang-long Zhi-xiao Granule placebo
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
December 01, 2024

Study 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.