Efficacy and Safety of Beta-glucan Supplement in Chronic Obstructive Pulmonary Disease Patients
1 other identifier
interventional
72
0 countries
N/A
Brief Summary
The objectives of this study are to evaluate Efficacy and safety of beta-glucan supplement in chronic obstructive pulmonary disease patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2023
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2023
CompletedStudy Start
First participant enrolled
May 25, 2023
CompletedFirst Posted
Study publicly available on registry
May 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2023
CompletedMay 30, 2023
May 1, 2023
6 months
May 18, 2023
May 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Forced expiratory volume in 1 second/Forced vital capacity
Forced expiratory volume in 1 second/Forced vital capacity in % (high value means better pulmonary function)
12 weeks
Secondary Outcomes (12)
Modified Medical Research Council Dyspnea Score
12 weeks
Breathlessness, Cough, and Sputum Scale
12 weeks
6-minute walk test
12 weeks
Chronic obstructive pulmonary disease assessment test
12 weeks
Tumor necrosis factor alpha
12 weeks
- +7 more secondary outcomes
Study Arms (2)
Beta-glucan supplement group
EXPERIMENTALBeta-glucan supplement capsule composes of beta-glucan 250 mg, broccoli 75 mg, quercetin 50 mg.
Placebo group
PLACEBO COMPARATORPlacebo capsule is empty capsule.
Interventions
Take 1 capsule 1 time per day for 12 weeks.
Eligibility Criteria
You may qualify if:
- Age more than 18 years
- Chronic Obstructive Pulmonary Disease with Forced expiratory volume in 1 second/Forced vital capacity after receiving bronchodilator medicine more than 70%
- No exacerbation and uncontrolled disease
- pack-years smoking history 10 pack-years but stop smoking more than 1 years
- Willing to participate in this study
You may not qualify if:
- Respiratory infection in 4 weeks
- Lung cancer
- Liver disease or kidney disease
- Lung surgery history
- Take kung supplement in 2 weeks
- Take warfarin, clopidogrel, aspirin, or digoxin
- Allergic to beta-glucan, broccoli, or quercetin
- Cannot use Spirometry
- Pregnancy and lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
Pornanong Aramwit, Professor
Chulalongkorn University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 18, 2023
First Posted
May 26, 2023
Study Start
May 25, 2023
Primary Completion
November 30, 2023
Study Completion
December 20, 2023
Last Updated
May 30, 2023
Record last verified: 2023-05