Polycan in Combination With Glucosamine for Treatment of Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Osteoarthritis of the Knee
• Interventions: Dietary Supplement: Polycan 50mg + Glucosamine 1500 mg; Dietary Supplement: Glucosamine 1500 mg; Dietary Supplement: Polycan 50mg + Glucosamine 750 mg

• Registration Number: NCT03717714
• Lead Sponsor: Vietstar Biomedical Research

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-01
• Primary Completion: 2018-05-30
• Study Completion: 2018-05-30
• Status Verified: 2018-10
• Study First Submitted: 2018-10-20
• Study First Submitted QC: 2018-10-22
• Last Update Submitted: 2018-10-22
• Study First Posted: 2018-10-24
• Last Update Posted: 2018-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polycan & Glucosamine 1500mg	Polycan 50mg + Glucosamine 1500 mg	Polycan 50 mg + Glucosamine 1500 mg per day
Glucosamine 1500mg	Glucosamine 1500 mg	Glucosamine 1500 mg per day for 12 weeks
Polycan & Glucosamine 750mg	Polycan 50mg + Glucosamine 750 mg	Polycan 50 mg + Glucosamine 750 mg per day for 12 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

198 Hospital; 🇻🇳 Hanoi, Vietnam