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Ginger's Therapeutic Potential in Asthma (GINGER)

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ClinicalTrials.gov Identifier: NCT03705832
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : February 1, 2019
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Emily DiMango, MD, Columbia University

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Ginger Extract Drug: Placebo Early Phase 1

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ginger's Therapeutic Potential in Asthma
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Active drug
Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days.
Drug: Ginger Extract
2gm Capsule of Ginger extract
Other Name: Ginger

Placebo Comparator: Placebo
Subjects assigned to the placebo group will receive a matching placebo for 56 days.
Drug: Placebo
Matching Placebo




Primary Outcome Measures :
  1. Methacholine Challenge Test [ Time Frame: 56 days ]
    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 concentration (PC)20 values will be used to measure any change in airway hyperresponsiveness.


Secondary Outcome Measures :
  1. Change in Serum Cytokines [ Time Frame: 56 days ]
    Measure of markers of asthmatic lung inflammation

  2. Change in Eosinophilia [ Time Frame: 56 days ]
    Measure of markers of asthmatic lung inflammation

  3. Change in Fractional Exhaled Nitric Oxide (FeNO) [ Time Frame: 56 days ]
    Measure of markers of asthmatic lung inflammation

  4. Score on the Asthma Control Test (ACT) [ Time Frame: 56 days ]
    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.

  5. Score on Juniper mini-Asthma specific Quality of Life (Mini AQLQ-J) [ Time Frame: 56 days ]
    This questionnaire consists of 15 items in 4 domains with a 2-week recall period. Scores range 1-7, with higher scores indicating better quality of life.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03705832


Contacts
Contact: Emily DiMango, MD (212)305-0631 ead3@columbia.edu
Contact: Charles Emala, MD 212-305-8360

Locations
United States, New York
Columbia University Asthma Center Recruiting
New York, New York, United States, 10032
Contact: Emily DiMango, MD    212-305-4675    ead3@columbia.edu   
Sub-Investigator: Charles Emala, MD         
Principal Investigator: Emily DiMango, MD         
Sponsors and Collaborators
Emily DiMango, MD
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Emily DiMango, MD Columbia University

Responsible Party: Emily DiMango, MD, Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT03705832     History of Changes
Other Study ID Numbers: AAAR8427
R61AT009989 ( U.S. NIH Grant/Contract )
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Emily DiMango, MD, Columbia University:
Ginger
Dietary supplement

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases