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

Cough Clinical Trial

Official title:

Evaluation of the Three-Seeds Mixture Treatment in Chronic Obstructive Pulmonary Disease Patients: A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03926884
• Other study ID #: A1248
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: April 2019
• Source: Veterans Affairs Medical Center, Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 30, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cough
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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
• Control
warm water with negligible amount of the three-seeds mixture

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Veterans Affairs Medical Center, Miami	Dr. Robert Jackson

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One month