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
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Ginger Extract Drug: Placebo||Early Phase 1|
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|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double blind placebo controlled|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- 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.
- Change in Serum Cytokines [ Time Frame: 56 days ]Measure of markers of asthmatic lung inflammation
- Change in Eosinophilia [ Time Frame: 56 days ]Measure of markers of asthmatic lung inflammation
- Change in Fractional Exhaled Nitric Oxide (FeNO) [ Time Frame: 56 days ]Measure of markers of asthmatic lung inflammation
- 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.
- 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.
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
|Contact: Emily DiMango, MD||(212)firstname.lastname@example.org|
|Contact: Charles Emala, MD||212-305-8360|
|United States, New York|
|Columbia University Asthma Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Emily DiMango, MD 212-305-4675 email@example.com|
|Sub-Investigator: Charles Emala, MD|
|Principal Investigator: Emily DiMango, MD|
|Principal Investigator:||Emily DiMango, MD||Columbia University|