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Clinical study on the effect of Hanchuan Zupa Granule on the control rate of bronchial asthma

Clinical study on the effect of Hanchuan Zupa Granule on the control rate of bronchial asthma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086925
Enrollment
Unknown
Registered
2024-07-15
Start date
2021-04-21
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Bronchial asthma

Interventions

Experimental drug set:Western medicine basic treatment + Hanchuan Zupa granules
Placebo group:Western medicine basic treatment + Hanchuan Zupa granule simulator

Sponsors

China-japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Patients who meet the Western medical diagnosis of bronchial asthma; (2) Patients who meet the cold croup syndrome of traditional Chinese medicine; (3) Patients with chronic duration and Asthma Control Test (ACT) questionnaire score < 20; (4) Age 18-65 years old (including 18 and 65 years old); (5) Sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) previous fatal asthma attacks; (2) Occupational asthma; (3) Seasonal asthma; (4) Combined with structural lung diseases such as thoracic malformation, chronic obstructive pulmonary disease, bronchiectasis, cystic pulmonary fibrosis, etc.; (5) Patients with serious primary diseases of the heart, brain, liver, kidney and hematopoietic system and mental illness; (6) Patients with primary immunodeficiency disease or acquired immunodeficiency syndrome; (7) Allergic to the drug ingredients in the known experimental drug; (8) Glutamic aminotransferase (ALT) and aspartate aminotransferase (AST) were more than 1.5 times the upper limit of normal value, and serum creatinine (Scr) was greater than the upper limit of normal value; (9) Pregnant, lactating and pregnant women; (10) Participate in other clinical studies within 1 month prior to screening; (11) Participants considered unsuitable for this clinical trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Good asthma control rate, week 4 assessment;

Secondary

MeasureTime frame
Asthma control level (total control, partial control, proportion of uncontrolled people), week 4 evaluation;The change value and change rate of TCM syndrome score were evaluated at week 2 and week 4;The change in the number of press-weekly use of palliative drugs (salbutamol aerosol) was evaluated at week 2 and week 4;Changes in Asthma Quality of Life Questionnaire (Mini-AQLQ) scores were evaluated at week 2 and week 4;Changes in Asthma Quality of Life Questionnaire (Mini-AQLQ) scores were evaluated at week 2 and week 4;Peak expiratory flow velocity (PEF) measurements and changes were evaluated at week 2 and week 4;FEV1, FVC, FEV1/FVC measurements and changes before and after bronchodilator were evaluated at week 4;

Countries

China

Contacts

Public ContactLin Jiangtao

China-japan Friendship Hospital

jiangtao_L@263.net+86 135 0115 8163

Outcome results

None listed

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