Chronic Obstructive Pulmonary Disease PatientsNCT05878834
Efficacy and Safety of Beta-glucan Supplement in Chronic Obstructive Pulmonary Disease Patients
A study testing Beta-glucan supplement group in people with Chronic Obstructive Pulmonary Disease Patients, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The objectives of this study are to evaluate Efficacy and safety of beta-glucan supplement in chronic obstructive pulmonary disease patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease Patients
- What is being tested?
- Beta-glucan supplement group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteThailand
- Study dates
- 25 May 2023to 10 Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18 years
- Chronic Obstructive Pulmonary Disease with Forced expiratory volume in 1 second/Forced vital capacity after receiving bronchodilator medicine less than or equal to 70%
- No exacerbation and uncontrolled disease
- Willing to participate in this study
Who cannot join
- Respiratory infection in 4 weeks
- Lung cancer, abnormal pulmonary lesions on chest radiography
- Liver disease or kidney disease
- Lung surgery history
- Take lung supplement in 2 weeks
- Take warfarin, clopidogrel, aspirin, or digoxin
Show all 9Show fewer
- Allergic to beta-glucan, broccoli, or quercetin
- Cannot use Spirometry
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of this study are to evaluate Efficacy and safety of beta-glucan supplement in chronic obstructive pulmonary disease patients.
Read the detailed description
There are 42 patients in this study. They are randomly divided into 2 groups which are beta-glucan supplement group and placebo group. The supplement will be taken 1 capsule/day for 12 weeks. Forced expiratory volume in 1 second, Forced expiratory volume in 1 second/Forced vital capacity, Modified Medical Research Council Dyspnea Score, Breathlessness, Cough, and Sputum Scale, 6 Minute Walk Test, Diffusing capacity for carbon monoxide, Tumor necrosis factor alpha, Interleukin-6, C-reactive protein, glutathione, aspartate transaminase, alanine transaminase, alkaline phosphatase, creatinine, and blood urea nitrogen are assessed before and after taking supplement 6 and 12 weeks.
- Being tested
- Beta-glucan supplement group, Placebo group
- Keywords
- chronic obstructive pulmonary, beta-glucan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-glucan supplement groupDietary supplement
Take 1 capsule 1 time per day for 12 weeks.
Placebo groupDietary supplement
Take 1 capsule 1 time per day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Beta-glucan supplement group | Experimental | Beta-glucan supplement capsule composes of beta-glucan 250 mg, broccoli 75 mg, quercetin 50 mg. Receives: Dietary Supplement: Beta-glucan supplement group |
| Placebo group | Placebo comparator | Placebo capsule is empty capsule. Receives: Dietary Supplement: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in 1 second
Forced expiratory volume in 1 second in % (high value means better pulmonary function)
Measured: 12 weeks
Secondary outcomes (12)
Modified Medical Research Council Dyspnea Score
Modified Medical Research Council Dyspnea Score shows in dyspnea score (score 0 to 4 means low dyspnea to high severity).
Measured: 12 weeks
Breathlessness, Cough, and Sputum Scale
Breathlessness, Cough, and Sputum Scale shows in severity scale (scale 0 to 4 means no symptom to high severity)
Measured: 12 weeks
6-minute walk test
6-minute walk test in walking distance in 6 minutes (meters) (high value means better performance)
Measured: 12 weeks
Chronic obstructive pulmonary disease assessment test
Chronic obstructive pulmonary disease assessment test in scale 0 to 5 (high value means better quality of life)
Measured: 12 weeks
Tumor necrosis factor alpha
Tumor necrosis factor alpha is a pro-inflammatory cytokine (picogram/ml) (high value means high risk of inflammation)
Measured: 12 weeks
Interleukin-6
Interleukin-6 is a biomarker of inflammation (picogram/ml) (high value means high risk of inflammation)
Measured: 12 weeks
C-reactive protein
C-reactive protein refers to inflammation (mg/ml) (high value means high risk of inflammation)
Measured: 12 weeks
Aspartate transaminase
Aspartate transaminase refers to liver function (U/L)
Measured: 12 weeks
Alanine transaminase
Alanine transaminase refers to liver function (U/L)
Measured: 12 weeks
Alkaline phosphatase
Alkaline phosphatase refers to liver function (U/L)
Measured: 12 weeks
Creatinine
Creatinine refers to renal function (mg/dl)
Measured: 12 weeks
Blood urea nitrogen
Blood urea nitrogen refers to renal function (mg/dl)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start25 May 2023
- Primary completion30 Nov 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease PatientsStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
- Investigators
- Pornanong Aramwit, Professor, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878834
- Sponsor's protocol ID
- Oh87/65
- Status last verified
- Sep 2026
- First submitted
- 18 May 2023
- Last updated
- 5 Oct 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Beta-glucan Supplement in Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT05878834
- Acronym / sponsor ID
- Oh87/65
- Keywords
- chronic obstructive pulmonary, beta-glucan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 25 May 2023 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 26 May 2023 (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 objectives of this study are to evaluate Efficacy and safety of beta-glucan supplement in chronic obstructive pulmonary disease patients.
Detailed description
There are 42 patients in this study. They are randomly divided into 2 groups which are beta-glucan supplement group and placebo group. The supplement will be taken 1 capsule/day for 12 weeks. Forced expiratory volume in 1 second, Forced expiratory volume in 1 second/Forced vital capacity, Modified Medical Research Council Dyspnea Score, Breathlessness, Cough, and Sputum Scale, 6 Minute Walk Test, Diffusing capacity for carbon monoxide, Tumor necrosis factor alpha, Interleukin-6, C-reactive protein, glutathione, aspartate transaminase, alanine transaminase, alkaline phosphatase, creatinine, and blood urea nitrogen are assessed before and after taking supplement 6 and 12 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta-glucan supplement group | Experimental | Dietary Supplement: Beta-glucan supplement groupBeta-glucan supplement capsule composes of beta-glucan 250 mg, broccoli 75 mg, quercetin 50 mg. |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo groupPlacebo capsule is empty capsule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age more than 18 years
- Chronic Obstructive Pulmonary Disease with Forced expiratory volume in 1 second/Forced vital capacity after receiving bronchodilator medicine less than or equal to 70%
- No exacerbation and uncontrolled disease
- Willing to participate in this study
Key exclusion criteria (9 listed)
- Respiratory infection in 4 weeks
- Lung cancer, abnormal pulmonary lesions on chest radiography
- Liver disease or kidney disease
- Lung surgery history
- Take lung supplement in 2 weeks
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 |
|---|---|---|
| Beta-glucan supplement groupTake 1 capsule 1 time per day for 12 weeks. | Dietary supplement | Beta-glucan supplement group |
| Placebo groupTake 1 capsule 1 time per day for 12 weeks. | Dietary supplement | Placebo group |
Primary outcome
Forced expiratory volume in 1 second
Time frame: 12 weeks
Forced expiratory volume in 1 second in % (high value means better pulmonary function)
12 secondary outcomes
Modified Medical Research Council Dyspnea Score
Time frame: 12 weeks
Breathlessness, Cough, and Sputum Scale
Time frame: 12 weeks
6-minute walk test
Time frame: 12 weeks
Chronic obstructive pulmonary disease assessment test
Time frame: 12 weeks
Tumor necrosis factor alpha
Time frame: 12 weeks
Interleukin-6
Time frame: 12 weeks
C-reactive protein
Time frame: 12 weeks
Aspartate transaminase
Time frame: 12 weeks
Alanine transaminase
Time frame: 12 weeks
Alkaline phosphatase
Time frame: 12 weeks
Creatinine
Time frame: 12 weeks
Blood urea nitrogen
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 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. This study is not recruiting at the moment.
Pornanong Aramwit, Professor principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beta-glucan supplement group in people with Chronic Obstructive Pulmonary Disease Patients, run by Chulalongkorn University at 1 site in Thailand.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Forced expiratory volume in 1 second (time frame: 12 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 5 Oct 2026.