A randomized, double-blind, parallel controlled, Phase II multicenter clinical trial of Maxing Zhixiao Granule in the treatment of bronchial asthma(heat asthma)

Phase 2

Not yet recruiting

• Conditions: bronchial asthma (heat asthma)

• Registration Number: ITMCTR2000004094
• Lead Sponsor: China-Japan Friendship Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-20

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Met the diagnostic criteria of Western medicine for bronchial asthma;
(2) In accordance with the diagnostic criteria of TCM asthma (Heat Asthma Syndrome);
(3) Chronic persistent patients with asthma control test (ACT) questionnaire score < 20;
(4) The severity of the disease was mild persistent and moderate persistent;
(5) The patients who did not use anti asthmatic drugs 2 weeks before the screening or those who had been treated with ICs or ICs + Laba for 4 weeks or more before enrollment, and the drug type and dose remained unchanged;
(6) Aged from 18 to 65 years old;
(7) Sign informed consent.

Exclusion Criteria

(1) Refractory asthma, critical asthma, occupational asthma, seasonal asthma, atypical asthma or upper and lower respiratory tract infection, pneumonia, pulmonary tuberculosis, pulmonary interstitial fibrosis, thoracic deformity, chronic obstructive pulmonary disease, bronchiectasis, cystic pulmonary fibrosis, allergic bronchiolitis, allergic granulomatous vasculitis and other special types, infectious and restrictive Pulmonary diseases and other air flow obstructive pulmonary diseases;
(2) Patients with severe primary diseases of heart, brain, liver, kidney and hematopoiesis and mental illness;
(3) Patients with primary immunodeficiency disease and acquired immunodeficiency syndrome;
(4) People with allergic constitution and allergic to the drug ingredients in the test drug;
(5) Glutamic transaminase (ALT) and aspartate aminotransferase (AST) were 1.5 times higher than the upper limit of normal value, and serum creatinine (CR) was higher than the upper limit of normal value;
(6) Pregnant, lactating and pregnant women;
(7) Participate in other clinical studies within one month before screening;
(8) Those who are considered unsuitable to participate in this clinical trial.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified