Asthma
Conditions
Keywords
Ginger, Dietary supplement
Brief summary
Primary Objective: The primary endpoint is a clinically significant improvement in tolerance to inhaled methacholine (PD20). Secondary Objectives: 1) To determine if oral daily ginger extract intake - decreases fractional excretion of nitric oxide; decreases blood eosinophilia; decreases asthma-associated cytokines in serum; decreases medium chain fatty acids; improves asthma symptoms; and 2) Establish pharmacokinetic parameters of biologically active components of ginger in adult asthmatics.
Detailed description
The study is based on preclinical evidence that active ginger components and their metabolites can relax airway smooth muscle and reduce lung inflammation, potentially through inhibition of phospholipase C (PLC), which is involved in both airway constriction and inflammatory cytokine release. The trial will evaluate whether oral ginger improves airway hyperresponsiveness, measured by tolerance to inhaled methacholine, and reduces markers of inflammation in adults with asthma. It will also assess the bioavailability and pharmacokinetics of active ginger metabolites. The selected ginger formulation and doses of 2-3 g/day were chosen based on prior human studies demonstrating generally good tolerability, with mostly mild gastrointestinal side effects. Because of limited evidence that ginger may affect platelet aggregation, participants taking anticoagulant medications will be excluded.
Interventions
DRUGGinger Extract
2gm or 3gm capsule of Ginger Extract
DRUGPlacebo
Matching placebo
Sponsors
Emily DiMango, MD
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 years or older with mild to severe persistent asthma as defined by NIH National Asthma Education and Prevention Program (NAEPP) guidelines, with asthma that is not optimally controlled despite current use of inhaled corticosteroids with or without inhaled long-acting beta agonists. 2. Treatment with inhaled corticosteroids (ICS), with or without long-acting beta-agonists/long-acting muscarinic antagonists and montelukast. 3. Physician-diagnosed asthma confirmed by history/report, pulmonary function testing with FEV1 ≥60% predicted or ≥1.5 L, and methacholine testing with baseline methacholine PD20 \<16 mg/mL if taking ICS or \<8 mg/mL if not taking ICS at Visit 2. 4. Non-smoker of tobacco, e-cigarettes, or marijuana for ≥1 year. Nicotine patch or gum is permitted. 5. Smoking history of ≤10 pack-years. 6. Suboptimal asthma control as determined by an Asthma Control Test (ACT) score ≤19 at the Screening and Randomization Visits. 7. Ability to understand English or Spanish, understand the study procedures, and comply with them f r the entire study period. 8. Participants of childbearing potential must have negative urine pregnancy testing as required by the protocol and agree to use effective contraception during the trial.
Exclusion criteria
1. Major chronic illness that, in the judgment of the study physician, would interfere with study participation, including non-skin cancer, uncontrolled diabetes mellitus, coronary artery disease, congestive heart failure, stroke, severe hypertension, renal failure, liver disorders, malabsorption disorders, immunodeficiency states, major neuropsychiatric disorders, or seizure disorders. 2. Cardiovascular conditions including myocardial infarction or stroke within the previous 3 months, uncontrolled hypertension, or known aortic aneurysm. 3. History of physician-diagnosed chronic bronchitis, emphysema, or COPD. 4. Current use of ginger supplements. 5. Oral corticosteroid use within the previous 6 weeks. 6. Use of an investigational treatment within the previous 30 days. 7. Use of anticoagulants, such as warfarin, rivaroxaban, or similar agents. 8. Known adverse reaction to ginger or ginger products. 9. Cancer other than skin cancer. 10. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. 11. Inability or unwillingness to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PD20 dose of methacholine | Baseline, 56 days | To measure any change in airway hyperresponsiveness following treatment with oral ginger compared with placebo, assessed by methacholine bronchoprovocation testing. Methacholine PD20 is the dose of inhaled methacholine that produces a 20% decrease in FEV1 from the post-diluent baseline. A clinically significant improvement is defined in the protocol as a 0.7 increase in the doubling dose of inhaled methacholine from the participant's baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fractional excretion of nitric oxide (FENO) | Baseline and 56 days | Measure of markers of asthmatic lung inflammation |
| Change in Blood Eosinophilia | Baseline and 56 days | Blood eosinophil counts will be used as a marker of asthma-associated inflammation. Blood samples will be obtained and processed. |
| Asthma-associated cytokines in serum level | Baseline, 56 days | To measure any change in levels of asthma-associated inflammatory cytokines following treatment with oral ginger compared with placebo. Cytokines will be measured in blood samples using multiplex cytokine analysis. |
| Medium chain fatty acids level | Baseline, 56 days | To measure any change in blood levels of medium-chain fatty acids following treatment with oral ginger compared with placebo. Medium-chain fatty acids will be assessed as biomarkers of asthma-associated inflammation. |
| ACT Score | 56 days | Asthma symptoms following treatment with oral ginger compared with placebo will be assessed using the Asthma Control Test (ACT). The ACT is a 5-question, 4-week recall questionnaire assessing asthma control, symptoms, and nocturnal awakenings, with scores ranging from 5 (poor control) to 25 (complete control). |
| Plasma concentration | 56 days | This is to measure pharmacokinetic parameters of biologically active components of ginger in adult asthmatics. Plasma concentrations of biologically active ginger components and/or metabolites will be measured and quantified in a subgroup of participants to characterize their pharmacokinetic profile. |
Countries
United States
Contacts
CONTACTEmily DiMango, MD
CONTACTCharles Emala, MD
PRINCIPAL_INVESTIGATOREmily DiMango, MD
Columbia University
Outcome results
None listed