Clinical trial NCT03705832: Ginger's Therapeutic Potential in Asthma
Official title: Ginger's Therapeutic Potential in Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Asthma
Keywords: Ginger
Dietary supplement
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2018-10-15
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind placebo controlled
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Change in Tolerance to Inhaled Methacholine
timeFrame: Baseline and Day 28
measure: Change in Tolerance to Inhaled Methacholine
timeFrame: Baseline and Day 56
measure: Change in Fractional Exhaled Nitric Oxide (FeNO)
timeFrame: Baseline and Day 28
measure: Change in Fractional Exhaled Nitric Oxide (FeNO)
timeFrame: Baseline and Day 56
Secondary outcomes:
measure: Change in Serum Cytokines
timeFrame: Baseline and Day 56
measure: Change in Eosinophilia
timeFrame: Baseline and Day 56
measure: Change in Score on the Asthma Control Test (ACT)
timeFrame: Baseline and Day 56
measure: Change In Score on Juniper Mini-Asthma Specific Quality of Life (Mini AQLQ-J)
timeFrame: Baseline and Day 56
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Asthma Center
state: New York
Study officials:
affiliation: Columbia University
name: Emily DiMango, MD
role: PRINCIPAL_INVESTIGATOR
References: