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

Veterans Affairs Medical Center, Miami

Status: Unknown

Conditions: Cough

Treatments: Dietary Supplement: Three-seeds mixture; Dietary Supplement: Control

Study type: Interventional

Funder types: Other U.S. Federal agency; Other

Identifiers

NCT03926884

A1248

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Tea1 group

Experimental group

Description:

This is the treatment group. This group will be taking 2 grams of the "three-seeds" mixture twice a day for three weeks.

Treatment:

Dietary Supplement: Three-seeds mixture

Tea2 group

Placebo Comparator group

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.

Treatment:

Dietary Supplement: Control