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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Three-seeds mixture

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

warm water with negligible amount of the three-seeds mixture

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Control

warm water with negligible amount of the three-seeds mixture

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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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Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No