COPDNCT07684391
Effect of Oral Astaxanthin Formula on Pulmonary Rehabilitation in Patients With COPD
A study testing Astaxanthin and Pulmonary rehabilitation training in people with COPD, run by China-Japan Friendship Hospital.
Trial summary
The goal of this clinical trial is to investigate whether an astaxanthin-based dietary supplement combined with a pulmonary rehabilitation training program could improve exercise capacity in patients with COPD. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Astaxanthin and Pulmonary rehabilitation training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who met the GOLD diagnostic criteria for stage II-IV COPD
- Patients who met the indications for pulmonary rehabilitation training: mMRC score
- 3 or self-reported decline in physical function.
Who cannot join
- Hypoxemia (resting partial pressure of oxygen < 60mmHg or oxygen saturation < 88%) or patients requiring continuous oxygen therapy or with any contraindications to exercise testing (refer to the American Society of Thoracic Surgeons/American College of Chest Physicians exercise testing guidelines).
- Using oral glucocorticoids
- Long-term oxygen therapy
- Participated in a supervised exercise program within the past 12 months
- History of other pulmonary diseases, including pneumoconiosis, bronchiectasis, tuberculosis, primary pulmonary hypertension, pulmonary embolism, interstitial lung disease
- Skeletal, neuromuscular, cardiovascular, or metabolic disorders that limit the participant's ability to exercise actively or that involve muscle activity, such as cancer, diabetes, muscle weakness, etc.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Oral Astaxanthin Formula Supplement on Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease: a Multicenter, Randomized Controlled Study
The goal of this clinical trial is to investigate whether an astaxanthin-based dietary supplement combined with a pulmonary rehabilitation training program could improve exercise capacity in patients with COPD. The main questions it aims to answer are:
- whether an astaxanthin-based dietary supplement combined with a pulmonary rehabilitation training program could improve 6MWD in patients with COPD.
Read more
The drug administration group will receive:
- Two capsules of astaxanthin formula supplement daily for 8 weeks.
- Pulmonary rehabilitation training: a total of 8 weeks, 2-3 times a week.
The control group will receive a total of 8-week pulmonary rehabilitation training, 2-3 times a week.
The investigators will compare the drug administration group and the control group to see if the difference between the 2 groups reaches a minimal clinically important difference.
- Conditions
- COPD
- Being tested
- Astaxanthin, Pulmonary rehabilitation training
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AstaxanthinDietary supplement
Two capsules of astaxanthin formula supplement daily for 8 weeks.
Pulmonary rehabilitation trainingBehavioural
A total of 8 weeks, 2-3 times per week. 1) Patient education: once a week, including disease explanation, chronic disease self-management awareness, and medication guidance. 2) Exercise training: 60 minutes each time, including 10 minutes of warm-up exercise, 40 minutes of aerobic exercise, and 10 minutes of stretching and relaxation (monitoring participants' working frequency, SpO2, heart rate, dyspnea score, and leg fatigue during exercise). 3) 20-min lower extremity endurance training (treadmill walking or treadmill exercise at 60% of 6MWT speed). 4) 20 minutes of lower limb strength training: squats, jump rope, straight leg raising exercises, etc.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Participants in this group will only receive an 8-week pulmonary rehabilitation training program and two placebo capsules daily for 8 weeks. Receives: Behavioral: Pulmonary rehabilitation training |
| Interventional group | Experimental | Participants in this group will receive an 8-week pulmonary rehabilitation training program combined with an astaxanthin dietary supplement. Receives: Dietary Supplement: Astaxanthin; Behavioral: Pulmonary rehabilitation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
6MWD change from baseline of two groups
The minimal clinically important difference of 6-minute walking distance of two groups.
Measured: Baseline and 8 weeks
Secondary outcomes (3)
Health-related quality of life of two groups
Using the COPD Assessment Test (CAT) to assess health-related quality of life. The CAT score ranges from 0 to 40, with higher scores indicating a worse outcome (a more severe impact of COPD on a patient's life).
Measured: Baseline and 8 weeks
Psychological status of two groups
Using the Hospital Anxiety and Depression Scale (HADS) to evaluate psychological status. The HADS consists of two subscales (Anxiety and Depression), each ranging from 0 to 21, for a maximum total score of 42. Higher scores indicate a worse outcome (higher levels of anxiety and depression).
Measured: Baseline and 8 weeks
Degree of dyspnea of two groups
Degree of dyspnea was assessed using the Modified Medical Research Council (mMRC) dyspnea scale. The mMRC scale ranges from 0 to 4, with higher scores indicating a worse outcome (more severe breathlessness).
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Hou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684391
- Sponsor's protocol ID
- ZRJY2021-BJ08-01-03
- Status last verified
- Jun 2026
- First submitted
- 13 Feb 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Astaxanthin Formula Supplement on Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease: a Multicenter, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07684391
- Acronym / sponsor ID
- ZRJY2021-BJ08-01-03
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Jul 2026 (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 goal of this clinical trial is to investigate whether an astaxanthin-based dietary supplement combined with a pulmonary rehabilitation training program could improve exercise capacity in patients with COPD. The main questions it aims to answer are:
- whether an astaxanthin-based dietary supplement combined with a pulmonary rehabilitation training program could improve 6MWD in patients with COPD.
The drug administration group will receive:
- Two capsules of astaxanthin formula supplement daily for 8 weeks.
- Pulmonary rehabilitation training: a total of 8 weeks, 2-3 times a week.
The control group will receive a total of 8-week pulmonary rehabilitation training, 2-3 times a week.
The investigators will compare the drug administration group and the control group to see if the difference between the 2 groups reaches a minimal clinically important difference.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Behavioral: Pulmonary rehabilitation trainingParticipants in this group will only receive an 8-week pulmonary rehabilitation training program and two placebo capsules daily for 8 weeks. |
| Interventional group | Experimental | Dietary Supplement: Astaxanthin, Behavioral: Pulmonary rehabilitation trainingParticipants in this group will receive an 8-week pulmonary rehabilitation training program combined with an astaxanthin dietary supplement. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who met the GOLD diagnostic criteria for stage II-IV COPD
- Patients who met the indications for pulmonary rehabilitation training: mMRC score
Key exclusion criteria (6 listed)
- Hypoxemia (resting partial pressure of oxygen < 60mmHg or oxygen saturation < 88%) or patients requiring continuous oxygen therapy or with any contraindications to exercise testing (refer to the American Society of Thoracic Surgeons/American College of Chest Physicians exercise testing guidelines).
- Using oral glucocorticoids
- Long-term oxygen therapy
- Participated in a supervised exercise program within the past 12 months
- History of other pulmonary diseases, including pneumoconiosis, bronchiectasis, tuberculosis, primary pulmonary hypertension, pulmonary embolism, interstitial lung disease
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 |
|---|---|---|
| AstaxanthinTwo capsules of astaxanthin formula supplement daily for 8 weeks. | Dietary supplement | Interventional group |
| Pulmonary rehabilitation trainingA total of 8 weeks, 2-3 times per week. 1) Patient education: once a week, including disease explanation, chronic disease self-management awareness, and medication guidance. 2) Exercise training: 60 minutes each time, including 10 minutes of warm-up exercise, 40 minutes of aerobic exercise, and 10 minutes of stretching and relaxation (monitoring participants' working frequency, SpO2, heart rate, dyspnea score, and leg fatigue during exercise). 3) 20-min lower extremity endurance training (treadmill walking or treadmill exercise at 60% of 6MWT speed). 4) 20 minutes of lower limb strength training: squats, jump rope, straight leg raising exercises, etc. | Behavioural | Control group, Interventional group |
Primary outcome
6MWD change from baseline of two groups
Time frame: Baseline and 8 weeks
The minimal clinically important difference of 6-minute walking distance of two groups.
3 secondary outcomes
Health-related quality of life of two groups
Time frame: Baseline and 8 weeks
Psychological status of two groups
Time frame: Baseline and 8 weeks
Degree of dyspnea of two groups
Time frame: Baseline and 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Astaxanthin and Pulmonary rehabilitation training in people with COPD, run by China-Japan Friendship Hospital.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 6 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingming Deng (86 18801336854, isdeng1017@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6MWD change from baseline of two groups (time frame: Baseline and 8 weeks). 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 6 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.