Back to resultsGinger's Therapeutic Potential in Asthma (GINGER)
Primary Purpose
Asthma
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ginger Extract
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Ginger, Dietary supplement
Eligibility Criteria
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.
Sites / Locations
- Columbia University Asthma Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active drug
Placebo
Arm Description
Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days.
Subjects assigned to the placebo group will receive a matching placebo for 56 days.
Outcomes
Primary Outcome Measures
Change in Tolerance to Inhaled Methacholine
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.
Change in Tolerance to Inhaled Methacholine
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.
Change in Fractional Exhaled Nitric Oxide (FeNO)
Measure of markers of asthmatic lung inflammation
Change in Fractional Exhaled Nitric Oxide (FeNO)
Measure of markers of asthmatic lung inflammation
Secondary Outcome Measures
Change in Serum Cytokines
Measure of markers of asthmatic lung inflammation
Change in Eosinophilia
Measure of markers of asthmatic lung inflammation
Change in Score on the Asthma Control Test (ACT)
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.
Change In Score on Juniper Mini-Asthma Specific Quality of Life (Mini AQLQ-J)
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.
Full Information
NCT ID
NCT03705832
First Posted
October 10, 2018
Last Updated
March 24, 2023
Sponsor
Emily DiMango, MD
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT03705832
Brief Title
Ginger's Therapeutic Potential in Asthma
Acronym
GINGER
Official Title
Ginger's Therapeutic Potential in Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 22, 2019 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emily DiMango, MD
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Ginger, Dietary supplement
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Double blind placebo controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active drug
Arm Type
Experimental
Arm Description
Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects assigned to the placebo group will receive a matching placebo for 56 days.
Intervention Type
Drug
Intervention Name(s)
Ginger Extract
Other Intervention Name(s)
Ginger
Intervention Description
2gm Capsule of Ginger extract
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo
Primary Outcome Measure Information:
Title
Change in Tolerance to Inhaled Methacholine
Description
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.
Time Frame
Baseline and Day 28
Title
Change in Tolerance to Inhaled Methacholine
Description
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.
Time Frame
Baseline and Day 56
Title
Change in Fractional Exhaled Nitric Oxide (FeNO)
Description
Measure of markers of asthmatic lung inflammation
Time Frame
Baseline and Day 28
Title
Change in Fractional Exhaled Nitric Oxide (FeNO)
Description
Measure of markers of asthmatic lung inflammation
Time Frame
Baseline and Day 56
Secondary Outcome Measure Information:
Title
Change in Serum Cytokines
Description
Measure of markers of asthmatic lung inflammation
Time Frame
Baseline and Day 56
Title
Change in Eosinophilia
Description
Measure of markers of asthmatic lung inflammation
Time Frame
Baseline and Day 56
Title
Change in Score on the Asthma Control Test (ACT)
Description
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.
Time Frame
Baseline and Day 56
Title
Change In Score on Juniper Mini-Asthma Specific Quality of Life (Mini AQLQ-J)
Description
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.
Time Frame
Baseline and Day 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily DiMango, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Asthma Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ginger's Therapeutic Potential in Asthma
We'll reach out to this number within 24 hrs