Ginger's Therapeutic Potential in Asthma

NCT07792395 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: ACYY2084R33AT012627
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Keywords

Ginger; Dietary supplement

Outcome Measures

Primary Outcomes (1)

• PD20 dose of methacholine

  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.

  Baseline, 56 days

Secondary Outcomes (6)

• 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

Study Arms (4)

Active drug - Placebo (2gm)

EXPERIMENTAL

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.

Drug: Ginger Extract; Drug: Placebo

Placebo - Active Drug (2gm)

EXPERIMENTAL

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.

Drug: Ginger Extract; Drug: Placebo

Active drug - Placebo (3gm)

EXPERIMENTAL

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.

Drug: Ginger Extract; Drug: Placebo

Placebo - Active Drug (3gm)

EXPERIMENTAL

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.

Drug: Ginger Extract; Drug: Placebo

Interventions

Ginger Extract DRUG

2gm or 3gm capsule of Ginger Extract

Also known as: Ginger

Active drug - Placebo (2gm); Active drug - Placebo (3gm); Placebo - Active Drug (2gm); Placebo - Active Drug (3gm)

Placebo DRUG

Matching placebo

Also known as: Placebo pill

Active drug - Placebo (2gm); Active drug - Placebo (3gm); Placebo - Active Drug (2gm); Placebo - Active Drug (3gm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 2.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emily DiMango, MD: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Columbia University Asthma Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

ginger extract

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Emily DiMango, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily DiMango, MD

CONTACT

(212)305-0631; ead3@columbia.edu

Charles Emala, MD

CONTACT

212-305-8360

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

US (1)