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The objectives of this study is to examine the Safety and Efficacy of black yeast beta-glucan produced from Aureobusidium pulluluns SM-2001 (Polycan), in combination with glucosamine in reducing knee osteoarthritis (OA) associated symptoms. This study is a double-blind, randomized, active-controlled trial conducted with 100 OA patients, aged 35-80 years using a formulated product
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucosamine 1500mg | Active Comparator | Glucosamine 1500 mg per day for 12 weeks |
|
| Polycan & Glucosamine 750mg | Experimental | Polycan 50 mg + Glucosamine 750 mg per day for 12 weeks |
|
| Polycan & Glucosamine 1500mg | Experimental | Polycan 50 mg + Glucosamine 1500 mg per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucosamine 1500 mg | Dietary Supplement | Patients in this group take 3 capsules, each capsule contains Placebo 16.7mg and Glucosamine 500 mg, once a day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) changes at 12 weeks in the three groups | The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing Stiffness (2 items): after first waking and later in the day Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties. Total WOMAC score ranges from 0 to 96 with higher scores indicate worse pain, stiffness, and functional limitations | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of dose of rescue medication (Meloxicam 7.5mg) used in the three groups. | Rescue medication (Meloxicam 7.5mg) used by patients for 12 weeks | Through study completion, an average of 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 198 Hospital | Hanoi | Vietnam |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D005944 | Glucosamine |
| ID | Term |
|---|---|
| D006595 | Hexosamines |
| D000606 | Amino Sugars |
| D002241 | Carbohydrates |
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| Polycan 50mg + Glucosamine 750 mg | Dietary Supplement | Patients in this group take 3 capsules, each capsule contains Polycan 16.7mg and Glucosamine 250 mg, once a day for 12 weeks |
|
| Polycan 50mg + Glucosamine 1500 mg | Dietary Supplement | Patients in this group take 3 capsules, each capsule contains Polycan 16.7mg and Glucosamine 500 mg, once a day for 12 weeks |
|
| D012216 |
| Rheumatic Diseases |