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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

Effect of add-on therapy with montelukast and CSBHT (chungsangboha-tang) in chronic persistent asthma patients: A randomized, placebo-control, parallel, multi-center trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0006005
Enrollment
210
Registered
2021-03-16
Start date
2021-05-01
Completion date
Unknown
Last updated
2021-03-22

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

Conditions

None listed

Interventions

Drug : intervention(CSBHT) and control (placebo), 1 pack 3 times a day for 8 weeks, 1 hr after meal

Sponsors

Kyung Hee University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
change of FEV1(forced expiratory volume in one second)

Secondary

MeasureTime frame
change of peak expiratory flow rate (PEFR);change of bronchoprovocation test and Fractional Exhaled Nitric Oxide (FeNO);change of St. George’s Respiratory Questionnaire (SGQR) and Asthma Control Test (ACT);frequency of rescue medicine;questionnaire of asthma symptoms of korean medicine;Serum IgE, eosinophil count, CRP

Countries

Korea, Republic of

Contacts

Public ContactBeom-Joon Lee

Kyung Hee University Hospital

Outcome results

None listed

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