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The objectives of this study are to evaluate Efficacy and safety of beta-glucan supplement in chronic obstructive pulmonary disease patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beta-glucan supplement group | Experimental | Beta-glucan supplement capsule composes of beta-glucan 250 mg, broccoli 75 mg, quercetin 50 mg. |
|
| Placebo group | Placebo Comparator | Placebo capsule is empty capsule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beta-glucan supplement group | Dietary Supplement | Take 1 capsule 1 time per day for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 weeks |
| Breathlessness, Cough, and Sputum Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pornanong Aramwit, Professor | Contact | +66899217255 | aramwit@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Pornanong Aramwit, Professor | Chulalongkorn University | Principal Investigator |
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| Placebo group | Dietary Supplement | Take 1 capsule 1 time per day for 12 weeks. |
|
Breathlessness, Cough, and Sputum Scale shows in severity scale (scale 0 to 4 means no symptom to high severity)
| 12 weeks |
| 6-minute walk test | 6-minute walk test in walking distance in 6 minutes (meters) (high value means better performance) | 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) | 12 weeks |
| Tumor necrosis factor alpha | Tumor necrosis factor alpha is a pro-inflammatory cytokine (picogram/ml) (high value means high risk of inflammation) | 12 weeks |
| Interleukin-6 | Interleukin-6 is a biomarker of inflammation (picogram/ml) (high value means high risk of inflammation) | 12 weeks |
| C-reactive protein | C-reactive protein refers to inflammation (mg/ml) (high value means high risk of inflammation) | 12 weeks |
| Aspartate transaminase | Aspartate transaminase refers to liver function (U/L) | 12 weeks |
| Alanine transaminase | Alanine transaminase refers to liver function (U/L) | 12 weeks |
| Alkaline phosphatase | Alkaline phosphatase refers to liver function (U/L) | 12 weeks |
| Creatinine | Creatinine refers to renal function (mg/dl) | 12 weeks |
| Blood urea nitrogen | Blood urea nitrogen refers to renal function (mg/dl) | 12 weeks |