- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03705832
Ginger's Therapeutic Potential in Asthma (GINGER)
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Columbia University Asthma Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men or women age 18 or older;
- Treatment with inhaled corticosteroids (ICS) +/- long acting β-agonists/long acting muscarinics and montelukast;
- Physician diagnosed asthma;
- Forced expiratory volume (FEV1) ≥60% of predicted
- Methacholine PC(20) < 16 mg/ml if taking ICS and < 8mg/ml if not taking ICS at Visit 2.
- Non-smoker (e.g., tobacco, e-cigarette, marijuana) for ≥1 yr.;
- ≤10 pack-year smoking history;
- 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:
- 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;
- Cardiovascular problems: Myocardial infarction or stroke in last 3 months Uncontrolled hypertension Known aortic aneurysm
- History of physician diagnosis of chronic bronchitis, emphysema or chronic obstructive pulmonary disease (COPD)
- 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;
- 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.
- Inability to perform acceptable and repeatable spirometry maneuvers throughout the test procedure.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active drug
Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days.
|
2gm Capsule of Ginger extract
Other Names:
|
Placebo Comparator: Placebo
Subjects assigned to the placebo group will receive a matching placebo for 56 days.
|
Matching Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Tolerance to Inhaled Methacholine
Time Frame: Baseline and Day 28
|
A methacholine challenge test is a medical test used to assist in the diagnosis of asthma.
The patient breathes in nebulized methacholine at gradually increasing doubling doses, starting with diluent only.
Methacholine provokes bronchoconstriction, or narrowing of the airways via M3 receptors.
The degree of narrowing can then be quantified by spirometry which is performed after inhalation of each dose.
Methacholine provocation dose (PD)20 values will be used to measure any change in airway hyperresponsiveness.
|
Baseline and Day 28
|
Change in Tolerance to Inhaled Methacholine
Time Frame: Baseline and Day 56
|
A methacholine challenge test is a medical test used to assist in the diagnosis of asthma.
The patient breathes in nebulized methacholine at gradually increasing doubling doses, starting with diluent only.
Methacholine provokes bronchoconstriction, or narrowing of the airways via M3 receptors.
The degree of narrowing can then be quantified by spirometry which is performed after inhalation of each dose.
Methacholine provocation dose (PD20) values will be used to measure any change in airway hyperresponsiveness.
|
Baseline and Day 56
|
Change in Fractional Exhaled Nitric Oxide (FeNO)
Time Frame: Baseline and Day 28
|
Measure of markers of asthmatic lung inflammation
|
Baseline and Day 28
|
Change in Fractional Exhaled Nitric Oxide (FeNO)
Time Frame: Baseline and Day 56
|
Measure of markers of asthmatic lung inflammation
|
Baseline and Day 56
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Serum Cytokines
Time Frame: Baseline and Day 56
|
Measure of markers of asthmatic lung inflammation
|
Baseline and Day 56
|
Change in Eosinophilia
Time Frame: Baseline and Day 56
|
Measure of markers of asthmatic lung inflammation
|
Baseline and Day 56
|
Change in Score on the Asthma Control Test (ACT)
Time Frame: Baseline and Day 56
|
Asthma symptom score will be measured with the Asthma Control Test at Visit 1, 2 and 5.This instrument, which has been validated for ages 12-84 years, is a 4-week recall questionnaire that addresses issues of asthma control, symptoms, and nocturnal awakenings.
The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control.
An ACT score >19 indicates well-controlled asthma.
|
Baseline and Day 56
|
Change In Score on Juniper Mini-Asthma Specific Quality of Life (Mini AQLQ-J)
Time Frame: Baseline and Day 56
|
This questionnaire consists of 15 items in 4 domains with a 2-week recall period.
Scores range from 7-105, with higher scores indicating better quality of life.
|
Baseline and Day 56
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAR8427
- R61AT009989 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
Johann Wolfgang Goethe University HospitalCompleted
-
Universita di VeronaCompleted
-
Parc de Salut MarActive, not recruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Value Outcomes Ltd.AstraZenecaCompletedAsthma, Bronchial | Bronchial Asthma | Asthma Chronic | Asthma; EosinophilicCzechia
-
Johann Wolfgang Goethe University HospitalCompletedExercise-induced AsthmaGermany
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States