Ginger's Therapeutic Potential in Asthma
Ginger's Therapeutic Potential in Asthma
This is a randomized, double blind, placebo controlled study to study whether there are
 potential benefits of consuming ginger by individuals with asthma.
Presently an estimated 25.9 million Americans suffer from asthma and over half have at least
 one asthma attack per year. Recent studies found that 60% of moderate asthmatics and 70% of
 severe asthmatics report using complementary and alternative medicine (CAM) to self-treat
 their asthma symptoms.The exact mechanism of action of these agents is unclear but may
 involve attenuation of allergic response, anti-inflammatory and antioxidant effects, and/or
 direct effects on airway smooth muscle which are responsible for airway narrowing in asthma.

 Studies done in mouse models of asthma and directly on airway smooth muscle cells demonstrate
 that ginger blocks one of the critical inflammatory pathways in asthma and thus leads to
 reduced airway inflammation and relaxation of airway smooth muscle. Clinical trials with
 chronic oral ginger therapy in humans have demonstrated safe consumption of 2 grams per day
 for 28 days with demonstrated anti-inflammatory effects in colon cancer and inflammatory
 bowel diseases. Thus, the investigators hypothesize that oral ginger at a dose of 2 grams per
 day will reduce airway inflammation and will reduce serum levels of asthma related
 inflammatory markers.
Inclusion Criteria:

 1. Men or women age 18 or older;

 2. Treatment with inhaled corticosteroids (ICS) +/- long acting β-agonists/long acting
 muscarinics and montelukast;

 3. Physician diagnosed asthma;

 4. Forced expiratory volume (FEV1) ≥60% of predicted

 5. Methacholine PC(20) < 16 mg/ml if taking ICS and < 8mg/ml if not taking ICS at Visit
 2.

 6. Non-smoker (e.g., tobacco, e-cigarette, marijuana) for ≥1 yr.;

 7. ≤10 pack-year smoking history;

 8. Suboptimal control of asthma as determined by a score < 19 or less on the Asthma
 Control Test (ACT) at Screening Visit (Visit 1) and Randomization Visit (Visit 3).

 Exclusion Criteria:

 1. Other major chronic illnesses: Conditions which in the judgment of the study physician
 would interfere with participation in the study, e.g., 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 disorder;

 2. Cardiovascular problems: Myocardial infarction or stroke in last 3 months Uncontrolled
 hypertension Known aortic aneurysm

 3. History of physician diagnosis of chronic bronchitis, emphysema or chronic obstructive
 pulmonary disease (COPD)

 4. Medication use: Current consumption of ginger supplements, oral corticosteroid use
 within the past 6 weeks, use of an investigational treatment in the previous 30 days,
 known adverse reaction to ginger or ginger products;

 5. Females of childbearing potential: Pregnant or lactating; participants of appropriate
 age who might be pregnant at the time of enrollment will be screened with urine
 pregnancy tests at each visit and cannot participate if pregnant. Participants must
 agree to use effective contraception during the trial.

 6. Inability to perform acceptable and repeatable spirometry maneuvers throughout the
 test procedure.