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Status unknownNCT03926884Updated Apr 25, 2019

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

An interventional study of Three-seeds mixture and Control in Cough, sponsored by Veterans Affairs Medical Center, Miami. Status unknown. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2019-04-25.

Sponsored by Veterans Affairs Medical Center, Miami · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cough
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In context

Lung Diseases, Obstructive

2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's planned enrollment of 80 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

Veterans Affairs Medical Center, Miami is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
80 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Dietary supplementThree-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

  • Dietary supplementControl

    warm water with negligible amount of the three-seeds mixture

06

What researchers measure

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.

    Time frame: One month

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03926884
Lead sponsor
Veterans Affairs Medical Center, Miami
Collaborators
Dr. Robert Jackson
Responsible party
Fei Tang (Research Health Scientist, Veterans Affairs Medical Center, Miami) — Principal investigator
First posted
Apr 25, 2019
Start date
Jun 1, 2019 (estimated)
Primary completion
Jun 1, 2020 (estimated)
Completion
Jun 30, 2020 (estimated)
Last update
Apr 25, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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