Efficacy of Oral PHLAI Capsule on Asthma Control and Airway Inflammation in Asthmatic Patients: A Multicenter Randomized Controlled Trial

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210322003

Enrollment

177

Registered

2021-03-22

Start date

2021-03-18

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Asthma Asthma

Interventions

PHLAI (Zingiber cassumunar) capule 8 mg ,PHLAI (Zingiber cassumunar) capule 16 mg ,Placebo capsule 16 mg

Experimental Drug,Experimental Drug,Placebo Comparator Drug

PHLAI 8 mg,PHLAI 16 mg,Placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Asthmatic patients aged 18 years or more, 2. Uncontrolled asthma despite of inhaled corticosteroid (ICS) or ICS plus long-acting beta2-agonists (ICS/LABA) with budesonide 400 mcg per day or more, or dose equivalence for at least 3 months, and one of following; Asthma Control Test (ACT) scores 17 or less, or history of at least 1 asthma exacerbation in the past year

Exclusion criteria

Exclusion criteria: 1. Smoking history 10 pack-years or more, 2. History of asthma exacerbation within 3 months, 3. FEV1 <60%, 4. Inability to perform spirometry or exhaled nitric oxide testing, 5. Treatment with leukotriene receptor antagonist, theophylline, antihistamine, COX inhibitors (eg. aspirin, diclofenac, celecoxib) within 2 weeks, 6. Comorbid diseases including COPD, lung fibrosis, bronchiectasis, heart disease, chronic kidney disease (GFR<50 mL/min), chronic liver disease (AST and/or ALT and/or bilirubin and/or alkaline phosphatase and/or GGT increase in 1.5 times of upper limit of normal level), malignancy, 7. White blood counts 4000 cells/mm3 or less, hemoglobin 10 g/dL or less, platelets 100,000 /mm3 or less, 8. Allergy to PHLAI (Zingiber cassumunar), 9. Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Asthma Control Test (ACT) scores At day 0, week 4, 8, and 12 Points	—

Secondary

Measure	Time frame
Fractional exhaled nitric oxide (FeNO) At day 0, week 4, 8, and 12 Parts per billion (ppb),Erythrocyte sedimentation rate (ESR) At day 0, week 4, 8, and 12 mm/hr,C-reactive protein (CRP) At day 0, week 4, 8, and 12 mg/L ,Blood eosinophil counts At day 0, week 4, 8, and 12 cells/mm3,Renal function At day 0, week 4, 8, and 12 BUN and Cr (mg/dL),Liver function At day 0, week 4, 8, and 12 Total bilirubin (mg/dL), AST, ALT, Alkaline phosphatase, and Gamma glutamyl transpeptidase (U/L),Asthma exacerbation At day 0, week 4, 8, and 12 Events	—

Measure

Time frame

Fractional exhaled nitric oxide (FeNO) At day 0, week 4, 8, and 12 Parts per billion (ppb),Erythrocyte sedimentation rate (ESR) At day 0, week 4, 8, and 12 mm/hr,C-reactive protein (CRP) At day 0, week 4, 8, and 12 mg/L ,Blood eosinophil counts At day 0, week 4, 8, and 12 cells/mm3,Renal function At day 0, week 4, 8, and 12 BUN and Cr (mg/dL),Liver function At day 0, week 4, 8, and 12 Total bilirubin (mg/dL), AST, ALT, Alkaline phosphatase, and Gamma glutamyl transpeptidase (U/L),Asthma exacerbation At day 0, week 4, 8, and 12 Events

—

Countries

Thailand

Contacts

Public ContactNarongkorn Saiphoklang

Faculty of Medicine, Thammasat University

M_narongkorn@hotmail.com029269794

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026