Ginger's Therapeutic Potential in Asthma

NCT03705832 | Completed Early Phase 1 Results DMC FDA Drug

• 2 other identifiers: AAAR8427R61AT009989
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double blind, placebo controlled study to study whether there are potential benefits of consuming ginger by individuals with asthma.

Conditions

Asthma

Keywords

Ginger; Dietary supplement

Outcome Measures

Primary Outcomes (4)

• Change in Tolerance to Inhaled Methacholine

  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 (PD)20 values will be used to measure any change in airway hyperresponsiveness.

  Baseline and Day 28

• Change in Tolerance to Inhaled Methacholine

  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.

  Baseline and Day 56

• Change in Fractional Exhaled Nitric Oxide (FeNO)

  Measure of markers of asthmatic lung inflammation

  Baseline and Day 28

• Change in Fractional Exhaled Nitric Oxide (FeNO)

  Measure of markers of asthmatic lung inflammation

  Baseline and Day 56

Secondary Outcomes (4)

• 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

Study Arms (2)

Active drug

EXPERIMENTAL

Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days.

Drug: Ginger Extract

Placebo

PLACEBO COMPARATOR

Subjects assigned to the placebo group will receive a matching placebo for 56 days.

Drug: Placebo

Interventions

Ginger Extract DRUG

2gm Capsule of Ginger extract

Also known as: Ginger

Active drug

Placebo DRUG

Matching Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• 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 2.
• 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).

You may not qualify if:

• 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.

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

Results Point of Contact

• Title: Emily DiMango, MD
• Organization: Columbia University

ead3@columbia.edu

212-305-0631

Study Officials

• Emily DiMango, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Double blind placebo controlled

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 15, 2018
• Study Start: August 22, 2019
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: March 27, 2023
• Results First Posted: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)