Effect of add-on therapy with montelukast and CSBHT (chungsangboha-tang) in chronic persist ent asthma patients: A randomized, placebo-control, parallel, multi-center trial
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0006005
- Lead Sponsor
- Kyung Hee University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 210
1) male and female aged 19-85
2) patients who have been diagnosed with asthma and treated for more than 4 weeks
3) patients who are administered ICS/LABA and montelukast or ICS and montelukast
4) patients who voluntarily decide to participate in this clinical trial and signs a consent form
1) Patients with serious abnormalities such as pneumonia, interstitial lung disease, and active pulmonary tuberculosis on chest X-ray examination
2) Patients who have been using maintenance therapy with oral steroids since 4 weeks ago, are receiving anti-IgE antibodies, or taking herbal medicines for asthma treatment.
3) more than AST/ALT twice the normal value or Cr 1.5 mg/dL.
4) chronic heart failure of class III or IV (New York Heart Association)
5) Patients with alcohol or other substance abuse/dependency or history
6) Patients with malignant tumors or a history of malignant tumors (however, if they have not recurred for more than 5 years, participation is possible)
7) Patients with a history of hypersensitivity reactions or allergies to research-related drugs
8) Patients who are unable to read and write or have cognitive impairment
9) Pregnant or lactating women
10) patients who participated in other clinical trials within recent 30 days prior to this clinical trial (based on the date of written consent)
11) If the researcher determines that it is inappropriate for participation in clinical research due to other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method