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Evaluation of the Three-Seeds Mixture Treatment in Chronic Obstructive Pulmonary Disease Patients

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ClinicalTrials.gov Identifier: NCT03926884
Recruitment Status : Not yet recruiting
First Posted : April 25, 2019
Last Update Posted : April 25, 2019
Sponsor:
Collaborator:
Dr. Robert Jackson
Information provided by (Responsible Party):
Fei Tang, Veterans Affairs Medical Center, Miami

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.

Condition or disease Intervention/treatment Phase
Cough Dietary Supplement: Three-seeds mixture Dietary Supplement: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Three-Seeds Mixture Treatment in Chronic Obstructive Pulmonary Disease Patients: A Pilot Study
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Experimental: Tea1 group
This is the treatment group. This group will be taking 2 grams of the "three-seeds" mixture twice a day for three weeks.
Dietary Supplement: Three-seeds mixture
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

Placebo Comparator: Tea2 group
This is the control group. This group will be taking 0.02 grams of the "three-seeds" mixture once a day for three weeks.
Dietary Supplement: Control
warm water with negligible amount of the three-seeds mixture




Primary Outcome Measures :
  1. Sputum and cough score [ Time Frame: One month ]
    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.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females ages 50-80 at the time of entry
  2. Non-smoker for at least 1 year
  3. Chronic bronchitis with Fev1 <80% and Fev1/ Fvc <0.7 and daily sputum production
  4. 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.
  5. 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

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Responsible Party: Fei Tang, Research Health Scientist, Veterans Affairs Medical Center, Miami
ClinicalTrials.gov Identifier: NCT03926884     History of Changes
Other Study ID Numbers: A1248
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases