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
Veterans Affairs Medical Center, Miami
Dr. Robert Jackson
Information provided by (Responsible Party):
Fei Tang, Veterans Affairs Medical Center, Miami
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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 :
- 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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