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

NCT03926884 | Unknown

• 1 other identifier: A1248
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cough

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Tea1 group

EXPERIMENTAL

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

Tea2 group

PLACEBO COMPARATOR

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

Interventions

Three-seeds mixture 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

Tea1 group

Control DIETARY_SUPPLEMENT

warm water with negligible amount of the three-seeds mixture

Tea2 group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females ages 50-80 at the time of entry
• Non-smoker for at least 1 year
• Chronic bronchitis with Fev1 \<80% and Fev1/ Fvc \<0.7 and daily sputum production
• 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.
• Ability and willingness to provide informed consent.

You may not qualify if:

• \. Current Smoker 2. Asthma or other respiratory diseases 3. Frail patients (unintended weight loss, long term fatigue). 4. Patients with acute COPD exacerbation

Sponsors & Collaborators

• Veterans Affairs Medical Center, Miami: lead
• Dr. Robert Jackson: collaborator

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Health Scientist

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 25, 2019
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 30, 2020
• Last Updated: April 25, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share