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

Henan University of Traditional Chinese Medicine

Status: Not yet enrolling

Conditions: Asthma Chronic

Treatments: Drug: Huang-long Zhi-xiao Granule; Drug: Huang-long Zhi-xiao Granule placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05841901

TCM for Asthma

Details and patient eligibility

About

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).]

Full 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.

Enrollment: 224 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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224 participants in 2 patient groups, including a placebo group

Huang-long Zhi-xiao Granule

Experimental group

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.

Treatment:

Drug: Huang-long Zhi-xiao Granule

Huang-long Zhi-xiao Granule placebo

Placebo Comparator group

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.

Treatment:

Drug: Huang-long Zhi-xiao Granule placebo