Osteoarthritis of the Knee
Conditions
Brief summary
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
Interventions
DIETARY_SUPPLEMENTPolycan 50mg + Glucosamine 1500 mg
Patients in this group take 3 capsules, each capsule contains Polycan 16.7mg and Glucosamine 500 mg, once a day for 12 weeks
DIETARY_SUPPLEMENTGlucosamine 1500 mg
Patients in this group take 3 capsules, each capsule contains Placebo 16.7mg and Glucosamine 500 mg, once a day for 12 weeks
DIETARY_SUPPLEMENTPolycan 50mg + Glucosamine 750 mg
Patients in this group take 3 capsules, each capsule contains Polycan 16.7mg and Glucosamine 250 mg, once a day for 12 weeks
Sponsors
Vietstar Biomedical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of knee osteoarthritis (OA) * OA ranging from grade 1 to grade 3 by Kellgren and Lawrence system * Agree to participate into the study
Exclusion criteria
* OA ranging from grade 4 by Kellgren and Lawrence system * Allergic or contradicted with oral NSAIDs (Meloxicam) * Pregnant and breastfeeding women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) changes at 12 weeks in the three groups | Baseline to Week 12 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of dose of rescue medication (Meloxicam 7.5mg) used in the three groups. | Through study completion, an average of 12 weeks | Rescue medication (Meloxicam 7.5mg) used by patients for 12 weeks |
Countries
Vietnam
Outcome results
None listed