Back to resultsEvaluation of the Three-Seeds Mixture Treatment in Chronic Obstructive Pulmonary Disease Patients
Primary Purpose
Cough
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Three-seeds mixture
Control
Sponsored by
About this trial
This is an interventional treatment trial for Cough
Eligibility Criteria
Inclusion Criteria:
- Males or females ages 50-80 at the time of entry
- Non-smoker for at least 1 year
- Chronic bronchitis with Fev1 <80% and Fev1/ Fvc <0.7 and daily sputum production
- Documentation of COPD. We define COPD as the presence of irreversible airflow obstruction, presence of emphysema on CT scan or both. This determination will be by the pulmonary physicians leading this study.
- Ability and willingness to provide informed consent.
Exclusion Criteria:
1. Current Smoker 2. Asthma or other respiratory diseases 3. Frail patients (unintended weight loss, long term fatigue). 4. Patients with acute COPD exacerbation
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tea1 group
Tea2 group
Arm Description
This is the treatment group. This group will be taking 2 grams of the "three-seeds" mixture twice a day for three weeks.
This is the control group. This group will be taking 0.02 grams of the "three-seeds" mixture once a day for three weeks.
Outcomes
Primary Outcome Measures
Sputum and cough score
Sputum and cough measured by Cough and Sputum Assessment Questionnaire. The minimum score of this questionnaire is 0, and the maximum score is 100, with lower scores indicating higher symptom/impact levels. The total score will be reported. The score will be summed to a total score.
Secondary Outcome Measures
Full Information
NCT ID
NCT03926884
First Posted
April 10, 2019
Last Updated
April 22, 2019
Sponsor
Veterans Affairs Medical Center, Miami
Collaborators
Dr. Robert Jackson
1. Study Identification
Unique Protocol Identification Number
NCT03926884
Brief Title
Evaluation of the Three-Seeds Mixture Treatment in Chronic Obstructive Pulmonary Disease Patients
Official Title
Evaluation of the Three-Seeds Mixture Treatment in Chronic Obstructive Pulmonary Disease Patients: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Anticipated)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Veterans Affairs Medical Center, Miami
Collaborators
Dr. Robert Jackson
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to test whether the three-seeds mixture tea reduces sputum and/or cough in COPD patients, and if so, to evaluate whether the three-seeds mixture changes the lung microbiome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tea1 group
Arm Type
Experimental
Arm Description
This is the treatment group. This group will be taking 2 grams of the "three-seeds" mixture twice a day for three weeks.
Arm Title
Tea2 group
Arm Type
Placebo Comparator
Arm Description
This is the control group. This group will be taking 0.02 grams of the "three-seeds" mixture once a day for three weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Three-seeds mixture
Intervention Description
mixture of white mustard seeds, radish seeds and beefsteak plant (Korean perilla, a species of Perilla in the mint family, widely cultivated and edible for humans; a daily food for Korean people; many Japanese people drink as tea) seeds
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
warm water with negligible amount of the three-seeds mixture
Primary Outcome Measure Information:
Title
Sputum and cough score
Description
Sputum and cough measured by Cough and Sputum Assessment Questionnaire. The minimum score of this questionnaire is 0, and the maximum score is 100, with lower scores indicating higher symptom/impact levels. The total score will be reported. The score will be summed to a total score.
Time Frame
One month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or females ages 50-80 at the time of entry
Non-smoker for at least 1 year
Chronic bronchitis with Fev1 <80% and Fev1/ Fvc <0.7 and daily sputum production
Documentation of COPD. We define COPD as the presence of irreversible airflow obstruction, presence of emphysema on CT scan or both. This determination will be by the pulmonary physicians leading this study.
Ability and willingness to provide informed consent.
Exclusion Criteria:
1. Current Smoker 2. Asthma or other respiratory diseases 3. Frail patients (unintended weight loss, long term fatigue). 4. Patients with acute COPD exacerbation
-
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Three-Seeds Mixture Treatment in Chronic Obstructive Pulmonary Disease Patients
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