Ginger's Therapeutic Potential in Asthma
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in Tolerance to Inhaled Methacholine
研究概览
简要总结
This is a randomized, double blind, placebo controlled study to study whether there are potential benefits of consuming ginger by individuals with asthma.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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).
排除标准
- •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.
研究组 & 干预措施
Active drug
Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days.
干预措施: Ginger Extract (Drug)
Placebo
Subjects assigned to the placebo group will receive a matching placebo for 56 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Tolerance to Inhaled Methacholine
时间窗: 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.
Change in Fractional Exhaled Nitric Oxide (FeNO)
时间窗: Baseline and Day 56
Measure of markers of asthmatic lung inflammation
次要结局
- Change in Serum Cytokines(Baseline and Day 56)
- Change in Eosinophilia(Baseline and Day 56)
- Change in Score on the Asthma Control Test (ACT)(Baseline and Day 56)
- Change In Score on Juniper Mini-Asthma Specific Quality of Life (Mini AQLQ-J)(Baseline and Day 56)
研究者
Emily DiMango, MD
Professor of Medicine
Columbia University