Ginger's Therapeutic Potential in Asthma (GINGER)

• ClinicalTrials.gov Identifier: NCT03705832
• Recruitment Status: Completed
• First Posted: October 15, 2018
• Results First Posted: March 27, 2023
• Last Update Posted: March 27, 2023
• Sponsor: Emily DiMango, MD
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): Emily DiMango, MD, Columbia University

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.

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 54 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
• Actual Study Start Date: August 22, 2019
• Actual Primary Completion Date: February 28, 2021
• Actual Study Completion Date: February 28, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. Change in Fractional Exhaled Nitric Oxide (FeNO) [ Time Frame: Baseline and Day 28 ]
   Measure of markers of asthmatic lung inflammation
4. Change in Fractional Exhaled Nitric Oxide (FeNO) [ Time Frame: Baseline and Day 56 ]
   Measure of markers of asthmatic lung inflammation

Secondary Outcome Measures :

1. Change in Serum Cytokines [ Time Frame: Baseline and Day 56 ]
   Measure of markers of asthmatic lung inflammation
2. Change in Eosinophilia [ Time Frame: Baseline and Day 56 ]
   Measure of markers of asthmatic lung inflammation
3. 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.
4. 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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, New York

Columbia University Asthma Center

New York, New York, United States, 10032

Sponsors and Collaborators

Emily DiMango, MD

National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Emily DiMango, MD; Columbia University

  Study Documents (Full-Text)

Documents provided by Emily DiMango, MD, Columbia University:

Study Protocol and Statistical Analysis Plan  [PDF] July 22, 2019

Informed Consent Form  [PDF] August 20, 2020

More Information

• Responsible Party: Emily DiMango, MD, Professor of Medicine, Columbia University
• ClinicalTrials.gov Identifier: NCT03705832
• Other Study ID Numbers: AAAR8427; R61AT009989 ( U.S. NIH Grant/Contract )
• First Posted: October 15, 2018
• Results First Posted: March 27, 2023
• Last Update Posted: March 27, 2023
• Last Verified: March 2023

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