Ginger's Therapeutic Potential in Asthma - Phase 2a
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- PD20 dose of methacholine
研究概览
简要总结
Primary Objective: The primary endpoint is a clinically significant improvement in tolerance to inhaled methacholine (PD20).
Secondary Objectives: 1) To determine if oral daily ginger extract intake - decreases fractional excretion of nitric oxide; decreases blood eosinophilia; decreases asthma-associated cytokines in serum; decreases medium chain fatty acids; improves asthma symptoms; and 2) Establish pharmacokinetic parameters of biologically active components of ginger in adult asthmatics.
详细描述
The study is based on preclinical evidence that active ginger components and their metabolites can relax airway smooth muscle and reduce lung inflammation, potentially through inhibition of phospholipase C (PLC), which is involved in both airway constriction and inflammatory cytokine release. The trial will evaluate whether oral ginger improves airway hyperresponsiveness, measured by tolerance to inhaled methacholine, and reduces markers of inflammation in adults with asthma. It will also assess the bioavailability and pharmacokinetics of active ginger metabolites.
The selected ginger formulation and doses of 2-3 g/day were chosen based on prior human studies demonstrating generally good tolerability, with mostly mild gastrointestinal side effects. Because of limited evidence that ginger may affect platelet aggregation, participants taking anticoagulant medications will be excluded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Adults aged 18 years or older with mild to severe persistent asthma as defined by NIH National Asthma Education and Prevention Program (NAEPP) guidelines, with asthma that is not optimally controlled despite current use of inhaled corticosteroids with or without inhaled long-acting beta agonists.
- •Treatment with inhaled corticosteroids (ICS), with or without long-acting beta-agonists/long-acting muscarinic antagonists and montelukast.
- •Physician-diagnosed asthma confirmed by history/report, pulmonary function testing with FEV1 ≥60% predicted or ≥1.5 L, and methacholine testing with baseline methacholine PD20 <16 mg/mL if taking ICS or <8 mg/mL if not taking ICS at Visit
- •Non-smoker of tobacco, e-cigarettes, or marijuana for ≥1 year. Nicotine patch or gum is permitted.
- •Smoking history of ≤10 pack-years.
- •Suboptimal asthma control as determined by an Asthma Control Test (ACT) score ≤19 at the Screening and Randomization Visits.
- •Ability to understand English or Spanish, understand the study procedures, and comply with them f r the entire study period.
- •Participants of childbearing potential must have negative urine pregnancy testing as required by the protocol and agree to use effective contraception during the trial.
排除标准
- •Major chronic illness that, in the judgment of the study physician, would interfere with study participation, including 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 disorders, or seizure disorders.
- •Cardiovascular conditions including myocardial infarction or stroke within the previous 3 months, uncontrolled hypertension, or known aortic aneurysm.
- •History of physician-diagnosed chronic bronchitis, emphysema, or COPD.
- •Current use of ginger supplements.
- •Oral corticosteroid use within the previous 6 weeks.
- •Use of an investigational treatment within the previous 30 days.
- •Use of anticoagulants, such as warfarin, rivaroxaban, or similar agents.
- •Known adverse reaction to ginger or ginger products.
- •Cancer other than skin cancer.
- •Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- •Inability or unwillingness to provide written informed consent.
研究组 & 干预措施
Active drug - Placebo (2gm)
Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days, followed by washout period, then will receive matching placebo for 56 days.
干预措施: Placebo (Drug)
Placebo - Active Drug (2gm)
Subjects assigned to the placebo group will receive a matching placebo for 56 days, followed by washout period, then will receive 2 grams daily of Ginger Extract for 56 days.
干预措施: Placebo (Drug)
Active drug - Placebo (3gm)
Subjects assigned to the intervention will receive 3 grams daily of Ginger Extract for 56 days, followed by washout period, then will receive matching placebo for 56 days.
干预措施: Placebo (Drug)
Placebo - Active Drug (3gm)
Subjects assigned to the placebo group will receive a matching placebo for 56 days, followed by washout period, then will receive 3 grams daily of Ginger Extract for 56 days.
干预措施: Placebo (Drug)
Placebo - Active Drug (3gm)
Subjects assigned to the placebo group will receive a matching placebo for 56 days, followed by washout period, then will receive 3 grams daily of Ginger Extract for 56 days.
干预措施: Ginger Extract (Drug)
Active drug - Placebo (2gm)
Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days, followed by washout period, then will receive matching placebo for 56 days.
干预措施: Ginger Extract (Drug)
Active drug - Placebo (3gm)
Subjects assigned to the intervention will receive 3 grams daily of Ginger Extract for 56 days, followed by washout period, then will receive matching placebo for 56 days.
干预措施: Ginger Extract (Drug)
Placebo - Active Drug (2gm)
Subjects assigned to the placebo group will receive a matching placebo for 56 days, followed by washout period, then will receive 2 grams daily of Ginger Extract for 56 days.
干预措施: Ginger Extract (Drug)
结局指标
主要结局
PD20 dose of methacholine
时间窗: Baseline, 56 days
To measure any change in airway hyperresponsiveness following treatment with oral ginger compared with placebo, assessed by methacholine bronchoprovocation testing. Methacholine PD20 is the dose of inhaled methacholine that produces a 20% decrease in FEV1 from the post-diluent baseline. A clinically significant improvement is defined in the protocol as a 0.7 increase in the doubling dose of inhaled methacholine from the participant's baseline.
次要结局
- Change in fractional excretion of nitric oxide (FENO)(Baseline and 56 days)
- Change in Blood Eosinophilia(Baseline and 56 days)
- Asthma-associated cytokines in serum level(Baseline, 56 days)
- Medium chain fatty acids level(Baseline, 56 days)
- ACT Score(56 days)
- Plasma concentration(56 days)
研究者
Emily DiMango, MD
Professor of Medicine
Columbia University