Last updated: May 6, 2024
Sponsor: Shanghai University of Traditional Chinese Medicine
Overall Status: Active - Recruiting
Phase
2
Condition
Asthma
Allergies & Asthma
Treatment
Jia Wei Yang He granule
Jia Wei Yang He granule Placebo
Clinical Study ID
NCT03299322
2016LCSY098
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patient diagnosed with chronic persistent asthma
- Annual uncontrollable time ≥ 3 months
- Patients who have given written informed consent
Exclusion
Exclusion Criteria:
- History of upper upper/lower respiratory infection in the previous 1 months
- History of long-term controller medication use for asthma (oral corticosteroid orintravenous corticosteroids therapy) within the preceding 1 months
- History of antibiotic use in the previous 1 months
- History of life-threatening asthma
- History of chronic lung diseases other than asthma, including but not limited tochronic obstructive pulmonary disease, bronchiectasis, emphysema, tuberculosis,sarcoidosis, pulmonary fibrosis, lung cancer, etc
- History of serious disease of the heart and cerebrovascular disease
- History of severe liver or renal dysfunction or disease
- History of severe disease in the hematopoietic system
- History of immunodeficiency (including, but not limited to, HIV positive detection, orother acquired or congenital immunodeficiency disease, or organ transplant history)
- History of any other condition (such as known drug or alcohol abuse or psychiatricdisorder) which, in the opinion of the investigator, may preclude the patient fromfollowing and completing the protocol
- Are currently enrolled in, or discontinued within the last 30 days from, a clinicaltrial involving an investigational product or non-approved use of a drug or device (other than the investigational product used in this study), or concurrently enrolledin any other type of medical research judged not to be scientifically or medicallycompatible with this study
- History of allergies to the component of the investigated drugs
- Smoking within the past year
- Contraindication to induced sputum collection method on history or examination
- Any serious medical condition which, in the opinion of the Investigator, would pose asignificant risk to the patient or interfere with the interpretation of safety,efficacy, or pharmacodynamic data
Study Design
Total Participants: 240
Treatment Group(s): 2
Primary Treatment: Jia Wei Yang He granule
Phase: 2
Study Start date:
October 01, 2017
Estimated Completion Date:
December 01, 2025
Study Description
Connect with a study center
Longhua Hospital Affiliated Shanghai University of TCM
Shanghai, Shanghai 200032
ChinaActive - Recruiting
Fengxian District traditional Chinese medicine hospital
Shanghai,
ChinaSite Not Available
Jingan district center hospital
Shanghai,
ChinaSite Not Available
Pudong Hospital
Shanghai,
ChinaSite Not Available
Shanghai TCM-Integrated Hospital
Shanghai,
ChinaSite Not Available
Shanghai eighth people's hospital
Shanghai,
ChinaSite Not Available
Xuhui district center hospita
Shanghai,
ChinaSite Not Available
Zhongshan Hospital affiliated fudan university
Shanghai,
ChinaSite Not Available
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