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A randomized, double-blind, placebo-controlled, dose-exploration, multicenter Phase II clinical trial of Jiuwei Shufeng Pingchuan Granules in the treatment of chronic persistent bronchial asthma (wind asthma syndrome)

A randomized, double-blind, placebo-controlled, dose-exploration, multicenter Phase II clinical trial of Jiuwei Shufeng Pingchuan Granules in the treatment of chronic persistent bronchial asthma (wind asthma syndrome)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072816
Enrollment
Unknown
Registered
2023-06-26
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-07-02

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

Conditions

Chronic Duration of Bronchial Asthma (Wind Asthma Syndrome)

Interventions

High-dose group:Jiuwei Shufeng Pingchuan Granules
Low-dose group:Jiuwei Shufeng Pingchuan Granule+Simulator
Placebo group:Jiuwei Shufeng Pingchuan Granule+Simulator

Sponsors

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for bronchial asthma in Western medicine; 2. Comply with the traditional Chinese medicine syndrome differentiation standards for asthma and wind asthma; 3. Patients with chronic duration and asthma control test (ACT) questionnaire score<20 points; 4. The severity of the condition is classified as mild persistent and moderate persistent; 5. Patients who have not been treated with anti asthma drugs for 2 weeks before administration or who have been treated with ICS or ICS+LABA/SABA for 4 weeks or more before administration and whose drug type and dosage remain unchanged; 6. Age range from 18 to 65 years old (including boundary values), regardless of gender; 7. Voluntarily participate and sign an informed consent form in writing.

Exclusion criteria

Exclusion criteria: 1. Patients with refractory asthma, critically ill asthma, occupational asthma, atypical asthma or concomitant pulmonary tuberculosis, pulmonary interstitial fibrosis, thoracic deformity, chronic obstructive pulmonary disease, bronchiectasis, cystic pulmonary fibrosis, allergic bronchopulmonary aspergillosis, allergic granulomatous vasculitis, and other special types, infectious and restrictive pulmonary diseases, as well as other airflow obstructive pulmonary diseases; 2. Patients who have previously been diagnosed with severe primary diseases of the heart, brain, liver, kidney, and hematopoietic systems, mental illness, primary immunodeficiency, or acquired immunodeficiency syndrome; 3. Those who are allergic to the drug components or excipients in the known experimental medication; 4. Glutamate transaminase (ALT) and aspartate aminotransferase (AST) are more than 1.5 times the upper limit of normal value, and serum creatinine (SCR) is more than the upper limit of normal value; 5. Pregnancy, lactation, and subjects with pregnancy plans within the next 6 months; 6. Patients with upper and lower respiratory tract infections or pneumonia within one month prior to screening; 7. Participate in other clinical researchers within one month prior to screening; 8. Researchers believe that it is not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Good control rate of asthma;

Secondary

MeasureTime frame
Asthma control level grading;Changes in Traditional Chinese Medicine Syndrome Score and Rate of Changes in Asthma Control Level Grading;

Countries

China

Contacts

Public ContactSuyun Li

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

lisuyun2000@126.com+86 139 3841 5502

Outcome results

None listed

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