Assessing Jia Wei Yang He Formula for treating persistent asthma
Clinical Assessment of Jia Wei Yang He Formula as a Plus Therapy in the Treatment of Persistent Asthma and Airway Microbiome Exploration Research
This study tests if adding a traditional herbal treatment called Jia Wei Yang He Formula can help people with persistent asthma feel better while they continue their regular asthma medications.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Shanghai University of Traditional Chinese Medicine Academic / other |
| Locations | 8 sites (Shanghai, Shanghai and 7 other locations) |
| Trial ID | NCT03299322 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Jia Wei Yang He Formula as an additional therapy for patients with persistent asthma. It aims to explore the variations in the airway microbiome in asthma patients undergoing treatment with Traditional Chinese Medicine. Participants will receive standard anti-asthma treatment alongside the Jia Wei Yang He Formula for a duration of four weeks. The study also considers patients who are hesitant to use conventional asthma medications due to side effects, offering them the herbal formula after validating its efficacy.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with chronic persistent asthma who have experienced uncontrollable symptoms for at least three months.
Not a fit: Patients with recent upper or lower respiratory infections, or those with a history of severe asthma or other chronic lung diseases, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide an alternative treatment option for asthma patients who are intolerant to standard therapies.
How similar studies have performed: While there is growing interest in the use of Traditional Chinese Medicine for asthma, this specific approach remains novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai and 7 other locations
- Longhua Hospital Affiliated Shanghai University of TCM — Shanghai, Shanghai, China (Recruiting)
- Fengxian District traditional Chinese medicine hospital — Shanghai, China (Not_yet_recruiting)
- Jingan district center hospital — Shanghai, China (Not_yet_recruiting)
- Pudong Hospital — Shanghai, China (Not_yet_recruiting)
- Shanghai eighth people's hospital — Shanghai, China (Not_yet_recruiting)
- Shanghai TCM-Integrated Hospital — Shanghai, China (Not_yet_recruiting)
- Xuhui district center hospita — Shanghai, China (Not_yet_recruiting)
- Zhongshan Hospital affiliated fudan university — Shanghai, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Zifeng Ma, Master
- Email: mzf05@126.com
- Phone: +8621-64385700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.