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| ID | Type | Description | Link |
|---|---|---|---|
| R61AT009989 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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This is a randomized, double blind, placebo controlled study to study whether there are potential benefits of consuming ginger by individuals with asthma.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active drug | Experimental | Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days. |
|
| Placebo | Placebo Comparator | Subjects assigned to the placebo group will receive a matching placebo for 56 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ginger Extract | Drug | 2gm Capsule of Ginger extract |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Cytokines | Measure of markers of asthmatic lung inflammation | Baseline and Day 56 |
| Change in Eosinophilia | Measure of markers of asthmatic lung inflammation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily DiMango, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Asthma Center | New York | New York | 10032 | United States |
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54 participants were enrolled and 12 participants were excluded due to: lost to follow-up, asthma controlled, lung function below threshold, on exclusionary medications, and not taking asthma medications. Eight participants were withdrawn due to an institutional COVID-19 research pause.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Drug | Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days. Ginger Extract: 2gm Capsule of Ginger extract |
| FG001 | Placebo | Subjects assigned to the placebo group will receive a matching placebo for 56 days. Placebo: Matching Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Drug | Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days. Ginger Extract: 2gm Capsule of Ginger extract |
| BG001 | Placebo | Subjects assigned to the placebo group will receive a matching placebo for 56 days. Placebo: Matching Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Nine active drug and seven placebo participants were analyzed due to: 1) low lung function at the time of the study visit (methacholine testing was withheld for safety reasons) and 2) during the COVID-19 pandemic, methacholine testing was discontinued, as it is an aerosol generating procedure. | Posted | Mean | Standard Deviation | mg/ml | Baseline and Day 28 |
|
Up to Day 78
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Drug | Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days. Ginger Extract: 2gm Capsule of Ginger extract |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronavirus Disease 2019 (COVID-19) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Absence Seizure | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily DiMango, MD | Columbia University | 212-305-0631 | ead3@columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 22, 2019 | Feb 27, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 20, 2020 | Apr 22, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C000713927 | ginger extract |
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Double blind placebo controlled
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| Placebo | Drug | Matching Placebo |
|
| Baseline and Day 56 |
| Change in Score on the Asthma Control Test (ACT) | Asthma symptom score will be measured with the Asthma Control Test at Visit 1, 2 and 5.This instrument, which has been validated for ages 12-84 years, is a 4-week recall questionnaire that addresses issues of asthma control, symptoms, and nocturnal awakenings. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma. | Baseline and Day 56 |
| Change In Score on Juniper Mini-Asthma Specific Quality of Life (Mini AQLQ-J) | This questionnaire consists of 15 items in 4 domains with a 2-week recall period. Scores range from 7-105, with higher scores indicating better quality of life. | Baseline and Day 56 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days.
Ginger Extract: 2gm Capsule of Ginger extract
| OG001 | Placebo | Subjects assigned to the placebo group will receive a matching placebo for 56 days. Placebo: Matching Placebo |
|
|
| Primary | 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. | Twelve active drug and three placebo participants were analyzed due to: 1) low lung function at the time of the study visit (methacholine testing was withheld for safety reasons) and 2) during the COVID-19 pandemic, methacholine testing was discontinued, as it is an aerosol generating procedure. | Posted | Mean | Standard Deviation | PD20 of methacholine (mg/ml) | Baseline and Day 56 |
|
|
|
| Primary | Change in Fractional Exhaled Nitric Oxide (FeNO) | Measure of markers of asthmatic lung inflammation | Eight placebo analyzed due to device malfunction. | Posted | Mean | Standard Deviation | fractional exhaled parts per billion | Baseline and Day 28 |
|
|
|
| Primary | Change in Fractional Exhaled Nitric Oxide (FeNO) | Measure of markers of asthmatic lung inflammation | Nine placebo analyzed due to device malfunction. | Posted | Mean | Standard Deviation | fractional exhaled parts per billion | Baseline and Day 56 |
|
|
|
| Secondary | Change in Serum Cytokines | Measure of markers of asthmatic lung inflammation | Cytokine samples were collected from 15 and 10 active and placebo participants respectively. | Posted | Mean | Standard Deviation | pg/ml | Baseline and Day 56 |
|
|
|
| Secondary | Change in Eosinophilia | Measure of markers of asthmatic lung inflammation | Posted | Mean | Standard Deviation | x10^9 cells/L | Baseline and Day 56 |
|
|
|
| Secondary | Change in Score on the Asthma Control Test (ACT) | Asthma symptom score will be measured with the Asthma Control Test at Visit 1, 2 and 5.This instrument, which has been validated for ages 12-84 years, is a 4-week recall questionnaire that addresses issues of asthma control, symptoms, and nocturnal awakenings. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 56 |
|
|
|
| Secondary | Change In Score on Juniper Mini-Asthma Specific Quality of Life (Mini AQLQ-J) | This questionnaire consists of 15 items in 4 domains with a 2-week recall period. Scores range from 7-105, with higher scores indicating better quality of life. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 56 |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Placebo | Subjects assigned to the placebo group will receive a matching placebo for 56 days. Placebo: Matching Placebo | 0 | 12 | 1 | 12 | 1 | 12 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |