Chronic Obstructive Pulmonary Disease Patients
Conditions
Keywords
chronic obstructive pulmonary, beta-glucan
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.
Interventions
DIETARY_SUPPLEMENTBeta-glucan supplement group
Take 1 capsule 1 time per day for 12 weeks.
DIETARY_SUPPLEMENTPlacebo group
Take 1 capsule 1 time per day for 12 weeks.
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forced expiratory volume in 1 second/Forced vital capacity | 12 weeks | Forced expiratory volume in 1 second/Forced vital capacity in % (high value means better pulmonary function) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breathlessness, Cough, and Sputum Scale | 12 weeks | Breathlessness, Cough, and Sputum Scale shows in severity scale (scale 0 to 4 means no symptom to high severity) |
| 6-minute walk test | 12 weeks | 6-minute walk test in walking distance in 6 minutes (meters) (high value means better performance) |
| Chronic obstructive pulmonary disease assessment test | 12 weeks | Chronic obstructive pulmonary disease assessment test in scale 0 to 5 (high value means better quality of life) |
| Tumor necrosis factor alpha | 12 weeks | Tumor necrosis factor alpha is a pro-inflammatory cytokine (picogram/ml) (high value means high risk of inflammation) |
| Interleukin-6 | 12 weeks | Interleukin-6 is a biomarker of inflammation (picogram/ml) (high value means high risk of inflammation) |
| Modified Medical Research Council Dyspnea Score | 12 weeks | Modified Medical Research Council Dyspnea Score shows in dyspnea score (score 0 to 4 means low dyspnea to high severity). |
| Aspartate transaminase | 12 weeks | Aspartate transaminase refers to liver function (U/L) |
| Alanine transaminase | 12 weeks | Alanine transaminase refers to liver function (U/L) |
| Alkaline phosphatase | 12 weeks | Alkaline phosphatase refers to liver function (U/L) |
| Creatinine | 12 weeks | Creatinine refers to renal function (mg/dl) |
| Blood urea nitrogen | 12 weeks | Blood urea nitrogen refers to renal function (mg/dl) |
| C-reactive protein | 12 weeks | C-reactive protein refers to inflammation (mg/ml) (high value means high risk of inflammation) |
Contacts
Primary ContactPornanong Aramwit, Professor
Outcome results
None listed