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Efficacy and safety of Maxing Zhixiao granules in the treatment of bronchial asthma (heat asthma) : a randomized double-blind placebo-controlled multicenter Phase III clinical trial

Efficacy and safety of Maxing Zhixiao granules in the treatment of bronchial asthma (heat asthma) : a randomized double-blind placebo-controlled multicenter Phase III clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000339
Enrollment
Unknown
Registered
2025-02-18
Start date
2025-02-28
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial asthma

Interventions

Control group:Maxing Zhihu granule simulator, 1 bag/time, 3 times/day, taken with boiling water.
Experimental group:Maxing Zhixiao granule 1 bag/time 3 times/day take with boiling water.

Sponsors

China-japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meet the western diagnostic criteria for bronchial asthma and the traditional Chinese diagnostic criteria for asthma disease and heat; (2) Patients with chronic duration and Asthma Control Test (ACT) questionnaire score < 20; (3) The severity of the disease was classified as mild and moderate; (4) Patients who had not been treated with antiasthmatic drugs for 2 weeks prior to screening or who had been treated with ICS or ICS+LABA prior to enrollment Patients with the same drug type and dose for 4 weeks or more; (5) Age 18-65 years old; (6) Sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Refractory asthma critical asthma occupational asthma seasonal asthma atypical asthma or combined up and down call Specific types such as aspiration infection tuberculosis pulmonary interstitial fibrosis thoracic malformation chronic obstructive pulmonary disease bronchiectasis cystic pulmonary fibrosis allergic bronchopulmonary aspergillosis allergic granulomatous vasculitis infectious restrictive pulmonary diseases and other airflow obstructive pulmonary diseases; (2) Patients with serious primary diseases of the heart brain liver kidney and hematopoietic system and mental illness; (3) Patients with primary immunodeficiency disease or acquired immunodeficiency syndrome; (4) Allergic to the pharmaceutical ingredients of known experimental drugs; (5) Glutamic aminotransferase (ALT) and aspartate aminotransferase (AST) were more than 1.5 times the upper limit of normal value Serum creatinine (Cr) is greater than the upper limit of normal value; (6) Women or partners who are pregnant breastfeeding and have plans to conceive within the next 3 months; (7) Participate in other clinical studies within 1 month prior to screening; (8) Participants considered unsuitable for this clinical trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Good asthma control rate at 8 weeks;

Secondary

MeasureTime frame
FEV1 and FVC measurements and changes before bronchodilators were used;TCM syndrome curative effect and integral change value;Weekly use of relievers (salbutamol sulfate inhaled aerosol);Acute asthma attack;Score change of Asthma Quality of Life Questionnaire (Mini-AQLQ);Asthma control level grading;Good asthma control rate;

Countries

China

Contacts

Public ContactLin Jiangtao

China-japan Friendship Hospital

jiangtao_l@263.net010-84205252

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026