A Study to Assess Jia Wei Yang He Formula as a Plus Therapy in the Treatment of Persistent Asthma

Launched by SHANGHAI UNIVERSITY OF TRADITIONAL CHINESE MEDICINE · Sep 30, 2017

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ClinConnect Summary

This clinical trial is studying a treatment called Jia Wei Yang He Formula to see if it can help people with severe asthma who have trouble controlling their symptoms. The researchers are looking to understand how this treatment affects asthma and the bacteria in the airways, which can play a role in the condition. They are currently recruiting participants aged 6 to 74 who have been diagnosed with chronic persistent asthma and have experienced uncontrolled symptoms for at least three months.

To join the study, participants must not have had recent respiratory infections, certain asthma medications, or antibiotic treatments in the past month. They also need to be free from other serious health issues that could interfere with the study or put them at risk. Participants will receive the Jia Wei Yang He Formula as part of their treatment and will be monitored closely to see how it affects their asthma. This trial offers a chance to explore a potential new therapy for asthma, and participants will be contributing to important research in this area.

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Eligibility criteria

• Inclusion Criteria:
• • Patient diagnosed with chronic persistent asthma
• • Annual uncontrollable time ≥ 3 months
• • Patients who have given written informed consent
• 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 or intravenous 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 to chronic 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, or other acquired or congenital immunodeficiency disease, or organ transplant history)
• • History of any other condition (such as known drug or alcohol abuse or psychiatric disorder) which, in the opinion of the investigator, may preclude the patient from following and completing the protocol
• • Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device (other than the investigational product used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible 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 a significant risk to the patient or interfere with the interpretation of safety, efficacy, or pharmacodynamic data