Polycan in Combination With Glucosamine for Treatment of Knee Osteoarthritis

Vietstar Biomedical Research

Status: Completed

Conditions: Osteoarthritis of the Knee

Treatments: Dietary Supplement: Polycan 50mg + Glucosamine 1500 mg; Dietary Supplement: Polycan 50mg + Glucosamine 750 mg; Dietary Supplement: Glucosamine 1500 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03717714

Polycan-VN01

Details and patient eligibility

About

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

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups

Glucosamine 1500mg

Active Comparator group

Description:

Glucosamine 1500 mg per day for 12 weeks

Treatment:

Dietary Supplement: Glucosamine 1500 mg

Polycan & Glucosamine 750mg

Experimental group

Description:

Polycan 50 mg + Glucosamine 750 mg per day for 12 weeks

Treatment:

Dietary Supplement: Polycan 50mg + Glucosamine 750 mg

Polycan & Glucosamine 1500mg

Experimental group

Description:

Polycan 50 mg + Glucosamine 1500 mg per day

Treatment:

Dietary Supplement: Polycan 50mg + Glucosamine 1500 mg