Ginger's Therapeutic Potential in Asthma
Ginger's Therapeutic Potential in Asthma - Phase 2a
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether taking ginger extract each day helps adults whose asthma is not well controlled with inhaled steroid medicine. It checks whether ginger helps the lungs tolerate an inhaled substance that narrows the airways, reduces signs of swelling, and improves symptoms. It also studies how the body handles the active parts of ginger.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older with ongoing mild to severe asthma that is not well controlled.
- Use inhaled steroids, with or without other listed asthma medicines.
- Have doctor-diagnosed asthma confirmed by your history and breathing tests. Tests must meet the study’s limits for airflow and response to methacholine, a substance that narrows airways.
- Have no tobacco, e-cigarette, or marijuana smoking for at least 1 year. Nicotine patches or gum are allowed.
- Have smoked no more than 10 pack-years total, such as 1 pack a day for 10 years.
- Have an Asthma Control Test score of 19 or less at both the screening and random assignment visits.
- Understand English or Spanish and be able to understand and follow study steps for the whole study.
- If you can become pregnant, have negative urine pregnancy tests and agree to use effective birth control during the study.
Who can't join
- Have a major long-term illness that the study doctor thinks would affect participation, or cancer other than skin cancer.
- Have had a heart attack or stroke in the past 3 months, uncontrolled high blood pressure, or a known aortic aneurysm (a bulge in the body’s main artery).
- Have doctor-diagnosed chronic bronchitis, emphysema, or COPD, which are long-term lung diseases.
- Currently take ginger supplements or have had a bad reaction to ginger or ginger products.
- Have taken steroid medicine by mouth in the past 6 weeks or an experimental treatment in the past 30 days.
- Take blood thinners, such as warfarin or rivaroxaban.
- Have current drug or alcohol use or dependence that the study doctor thinks would keep you from following study requirements.
- Cannot or do not want to give written consent to join the study.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (1)
NY
- Columbia University Asthma Center · New York, NY 10032More trials in New York