CoughNCT03926884
Evaluation of the Three-Seeds Mixture Treatment in Chronic Obstructive Pulmonary Disease Patients
A study testing Three-seeds mixture in people with Cough, run by Veterans Affairs Medical Center, Miami.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cough
- What is being tested?
- Three-seeds mixture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1. Current Smoker 2. Asthma or other respiratory diseases 3. Frail patients (unintended weight loss, long term fatigue). 4. Patients with acute COPD exacerbation
- -
About this study
Official title: Evaluation of the Three-Seeds Mixture Treatment in Chronic Obstructive Pulmonary Disease Patients: A Pilot Study
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
- Being tested
- Three-seeds mixture, Control
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-seeds mixtureDietary 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
ControlDietary supplement
warm water with negligible amount of the three-seeds mixture
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start1 Jun 2019 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Veterans Affairs Medical Center, Miami
- Sponsor type
- US federal agency
- Collaborators
- Dr. Robert Jackson
- Responsible party
- Principal investigator, Fei Tang, Veterans Affairs Medical Center, Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926884
- Sponsor's protocol ID
- A1248
- Status last verified
- Apr 2019
- First submitted
- 10 Apr 2019
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Three-Seeds Mixture Treatment in Chronic Obstructive Pulmonary Disease Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT03926884
- Acronym / sponsor ID
- A1248
- Conditions
- Cough
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Veterans Affairs Medical Center, MiamiUS federal agency
- Collaborators
- Dr. Robert Jackson
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 25 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tea1 group | Experimental | Dietary Supplement: Three-seeds mixtureThis is the treatment group. This group will be taking 2 grams of the "three-seeds" mixture twice a day for three weeks. |
| Tea2 group | Placebo comparator | Dietary Supplement: ControlThis is the control group. This group will be taking 0.02 grams of the "three-seeds" mixture once a day for three weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 1. Current Smoker 2. Asthma or other respiratory diseases 3. Frail patients (unintended weight loss, long term fatigue). 4. Patients with acute COPD exacerbation
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three-seeds mixturemixture 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 supplement | Tea1 group |
| Controlwarm water with negligible amount of the three-seeds mixture | Dietary supplement | Tea2 group |
Primary outcome
Sputum and cough score
Time frame: One month
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Three-seeds mixture in people with Cough, run by Veterans Affairs Medical Center, Miami.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sputum and cough score (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.