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

NCT05841901 | Unknown DMC

• 1 other identifier: TCM for Asthma
• Study Type: interventional
• Target: 224
• Locations: 0 countries
• Sites: N/A

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:

• \[Relying on the top-level experimental design, scientifically evaluated the efficacy and safety of Huang-long Zhi-xiao Granule in patients with chronic asthma (hot asthma), and provided evidence support for the clinical application of Classical Prescriptions.\]
• \[Through the retained sample to test Asthma-related inflammatory indicators, immunoglobulins, T cell subsets, etc. To investigate the mechanism of action of Huang-long Zhi-xiao Granule in patients with chronic duration of asthma (hot asthma).\]

Conditions

Asthma Chronic

Keywords

Huang-long Zhi-xiao Granule; Chronic persistent of asthma

Outcome Measures

Primary Outcomes (2)

• 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.

  Change from baseline CAT scores at week 4, 8, 21, 34，47 and 52.

• 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.

  Up to week 52.

Secondary Outcomes (10)

• Asthma exacerbation severity and hospitalization rate

  Week0(before treatment),week4、week8、week21、week34、week47and week52.

• Change in severity of chronic persistent disease

  Week0(before treatment),week4、week8、week21、week34、week47and week52.

• The dose used by glucocorticoids

  Week0(before treatment),week4、week8、week21、week34、week47 and week52.

• Rapid-acting beta2 agonists use drugs and doses

  Week0(before treatment),week8 and after follow-up（week52）

• Score for clinical signs and symptoms

  Week0(before treatment),week8 and after follow-up（week52）

Study Arms (2)

Huang-long Zhi-xiao Granule

EXPERIMENTAL

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.

Drug: Huang-long Zhi-xiao Granule

Huang-long Zhi-xiao Granule placebo

PLACEBO COMPARATOR

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.

Drug: Huang-long Zhi-xiao Granule placebo

Interventions

Huang-long Zhi-xiao Granule 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

Huang-long Zhi-xiao Granule placebo 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.

Huang-long Zhi-xiao Granule placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead
• The First Affiliated Hospital of Henan University of Traditional Chinese Medicine: collaborator
• Third Affiliated Hospital of Henan University of Traditional Chinese Medicine: collaborator

Study Officials

• Minghang Wang, MD

  Henan University of Traditonal Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minghang Wang, MD

CONTACT

0371-66248624; wmh107hn@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: May 3, 2023
• Study Start: June 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share