Ginger's Therapeutic Potential in Asthma

NCT ID: NCT03705832

Last Updated: 2023-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-22
• Study Completion Date: 2021-02-28

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.

Detailed Description

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active drug

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

Group Type: EXPERIMENTAL

Ginger Extract

Intervention Type: DRUG

2gm Capsule of Ginger extract

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo

Interventions

Ginger Extract

2gm Capsule of Ginger extract

Intervention Type: DRUG

Placebo

Matching Placebo

Intervention Type: DRUG

Other Intervention Names

Ginger

Eligibility Criteria

Inclusion Criteria

1. Men or women age 18 or older;

2. Treatment with inhaled corticosteroids (ICS) +/- long acting β-agonists/long acting muscarinics and montelukast;

3. Physician diagnosed asthma;

4. Forced expiratory volume (FEV1) ≥60% of predicted

5. Methacholine PC(20) < 16 mg/ml if taking ICS and < 8mg/ml if not taking ICS at Visit 2.

6. Non-smoker (e.g., tobacco, e-cigarette, marijuana) for ≥1 yr.;

7. ≤10 pack-year smoking history;

8. 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).

Exclusion Criteria

1. 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;

2. Cardiovascular problems: Myocardial infarction or stroke in last 3 months Uncontrolled hypertension Known aortic aneurysm

3. History of physician diagnosis of chronic bronchitis, emphysema or chronic obstructive pulmonary disease (COPD)

4. 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;

5. 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.

6. Inability to perform acceptable and repeatable spirometry maneuvers throughout the test procedure.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Emily DiMango, MD

OTHER

Sponsor Role: lead

Responsible Party

Emily DiMango, MD

Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Emily DiMango, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Asthma Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R61AT009989

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAR8427

Identifier Type: -

Identifier Source: org_study_id