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

NCT ID: NCT05841901

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-12-01

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.

Conditions

Asthma Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Huang-long Zhi-xiao Granule

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.

Group Type: EXPERIMENTAL

Huang-long Zhi-xiao Granule

Intervention Type: DRUG

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.

Huang-long Zhi-xiao Granule placebo

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.

Group Type: PLACEBO_COMPARATOR

Huang-long Zhi-xiao Granule placebo

Intervention Type: DRUG

The toncral group was given placebo Huang-long Zhi-xiao Granule.The course of treatment was the same as that of the experimental group.

Interventions

Huang-long Zhi-xiao Granule

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

Huang-long Zhi-xiao Granule placebo

The toncral group was given placebo Huang-long Zhi-xiao Granule.The course of treatment was the same as that of the experimental group.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Third Affiliated Hospital of Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Minghang Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Henan University of Traditonal Chinese Medicine

Central Contacts

Minghang Wang, MD

Role: CONTACT

wmh107hn@163.com

0371-66248624

Other Identifiers

TCM for Asthma

Identifier Type: -

Identifier Source: org_study_id