Polycan in Combination With Glucosamine for Treatment of Knee Osteoarthritis

Study Overview
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Brief Summary
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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

Official Title
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A Randomized, Double-blind, Active Controlled, 12-week Follow-up, Pilot Study to Evaluate the Safety and Efficacy of Polycan in Combination With Glucosamine for Treatment of Knee Osteoarthritis

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Dietary Supplement: Glucosamine 1500 mg
* Dietary Supplement: Polycan 50mg + Glucosamine 750 mg
* Dietary Supplement: Polycan 50mg + Glucosamine 1500 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glucosamine 1500mg<br>Glucosamine 1500 mg per day for 12 weeks | Dietary Supplement: Glucosamine 1500 mg<br>* Patients in this group take 3 capsules, each capsule contains Placebo 16.7mg and Glucosamine 500 mg, once a day for 12 weeks<br>|
| Experimental: Polycan & Glucosamine 750mg<br>Polycan 50 mg + Glucosamine 750 mg per day for 12 weeks | Dietary Supplement: Polycan 50mg + Glucosamine 750 mg<br>* Patients in this group take 3 capsules, each capsule contains Polycan 16.7mg and Glucosamine 250 mg, once a day for 12 weeks<br>|
| Experimental: Polycan & Glucosamine 1500mg<br>Polycan 50 mg + Glucosamine 1500 mg per day | Dietary Supplement: Polycan 50mg + Glucosamine 1500 mg<br>* Patients in this group take 3 capsules, each capsule contains Polycan 16.7mg and Glucosamine 500 mg, once a day for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |