Prevalence of asthma in Thailand 7%. Bronchial hyperresponsiveness is key feature of asthma. Compound D (active compound in Phlai) can bind cysteinyl leukotrienes receptor that play role for asthma Zingiber cassumunar Phlai capsule adult asthma bronchial hyperresponsiveness
Conditions
Interventions
Phlai capsules containing 16 mg of compound D (4 capsules) take once daily for 4 weeks,Placebo (4 capsules) take once daily for 4 weeks
Experimental Drug,Experimental Drug
Zingiber cassumunar (Phlai capsule),Placebo
Sponsors
Government Pharmaceutical Organization Thailand
Department of Pediatrics,
Faculty of medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Patients aged 18 years or older with a diagnosis of asthma at least 1 year by allergists or pulmonologist following to GINA guideline; 2)Clinical with partly or uncontrolled symptom with using a low to medium dose inhaled corticosteroid or combination of inhaled corticosteroid / long-acting beta2-agonists (ICS/LABA) during 3 months prior to the study; 3) Asthma control test (ACT) scores 19; 4) Baseline FEV1 70% of predicted value prior to the start of the study.
Exclusion criteria
Exclusion criteria: 1) History of smoking more than 10 pack-years; 2) Unable to perform effective spirometry; 3)History of taking these medication during 2 weeks before to study such as leukotriene receptor antagonist , theophylline, antihistamine, COX inhibitors; 4)Receiving systemic corticosteroid within 2 weeks before the first visit; 5) Receiving monoclonal anti-IgE or omalizumab within 6 months before the first visit; 6) Underlying chronic disease such as chronic obstructive pulmonary disease, pulmonary fibrosis , bronchiectasis , coronary disease , ischemic or hemorrhagic stroke , chronic kidney disease(GFR<50 mL/min) , chronic liver disease (AST and/or ALT and/or bilirubin and/or alkaline phosphatase and/or GGT more than 1.5 times of upper normal limit; 7) Allergy to compound of Phlai; 8) Patient with pregnancy or lactation; 9)Conditions or diseases could possibly influence the results of the study as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the change in provocative concentration of methacholine causing a 20% drop in FEV1 (PC20) 4 visits( baseline , end of week 4 , end of week 6 , end of week 10) Methacholine challenge test | — |
Secondary
| Measure | Time frame |
|---|---|
| fractional exhaled nitric oxide (FeNO), pulmonary function test and asthma control test (ACT) scores 4 visits( baseline , end of week 4 , end of week 6 , end of week 10) NiOX Vero analyzer for FeNO , spirometry , questionaire of ACT scores | — |
Contacts
Public ContactOrapan Poachanukoon
Faculty of medicine,Thammasat university
Outcome results
None listed