Ginger's Therapeutic Potential in Asthma

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double blind, placebo controlled study to study whether there are potential benefits of consuming ginger by individuals with asthma.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emily DiMango, MD
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)

Criteria

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.