Polycan in Combination With Glucosamine for Treatment of Knee Osteoarthritis

Vietstar Biomedical Research90 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Osteoarthritis of the Knee

Interventions

Glucosamine 1500 mgDIETARY_SUPPLEMENT

Patients in this group take 3 capsules, each capsule contains Placebo 16.7mg and Glucosamine 500 mg, once a day for 12 weeks

Polycan 50mg + Glucosamine 750 mgDIETARY_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 mgDIETARY_SUPPLEMENT

Patients in this group take 3 capsules, each capsule contains Polycan 16.7mg and Glucosamine 500 mg, once a day for 12 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

198 Hospital

Hanoi, Vietnam

Outcomes

Primary Outcomes

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

Time frame: Baseline to Week 12

Secondary Outcomes

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

Time frame: Through study completion, an average of 12 weeks

Data from ClinicalTrials.gov

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