Efficacy and Safety of Beta-glucan Supplement in Chronic Obstructive Pulmonary Disease Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Chulalongkorn University
- Enrollment
- 72
- Primary Endpoint
- Forced expiratory volume in 1 second/Forced vital capacity
Study Overview
Brief Summary
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 72 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 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •10 pack-years smoking history 10 pack-years but stop smoking more than 1 years
- •Willing to participate in this study
Exclusion Criteria
- •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
Arms & Interventions
Beta-glucan supplement group
Beta-glucan supplement capsule composes of beta-glucan 250 mg, broccoli 75 mg, quercetin 50 mg.
Intervention: Beta-glucan supplement group (Dietary Supplement)
Placebo group
Placebo capsule is empty capsule.
Intervention: Placebo group (Dietary Supplement)
Outcomes
Primary Outcomes
Forced expiratory volume in 1 second/Forced vital capacity
Time Frame: 12 weeks
Forced expiratory volume in 1 second/Forced vital capacity in % (high value means better pulmonary function)
Secondary Outcomes
- Modified Medical Research Council Dyspnea Score(12 weeks)
- Tumor necrosis factor alpha(12 weeks)
- Alkaline phosphatase(12 weeks)
- Aspartate transaminase(12 weeks)
- 6-minute walk test(12 weeks)
- Interleukin-6(12 weeks)
- Creatinine(12 weeks)
- Breathlessness, Cough, and Sputum Scale(12 weeks)
- Chronic obstructive pulmonary disease assessment test(12 weeks)
- C-reactive protein(12 weeks)
- Alanine transaminase(12 weeks)
- Blood urea nitrogen(12 weeks)
Investigators
Pornanong Aramwit, Pharm.D., Ph.D
Professor
Chulalongkorn University