Emily DiMango, MD
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.
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 formula…
Inclusion Criteria: 1. 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. 2. Treatment with inhaled corticosteroids (ICS), with or without long-acting beta-agonists/long-acting muscarinic antagonists and montelukast. 3. Physician-diagnosed asthma confirmed by history/report, pulmonary function testing with FEV1 ≥60% predicted or ≥1.5 L, and methachol…
2gm or 3gm capsule of Ginger Extract
Matching placebo
Arctuva estimate
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