Polycan in Combination With Glucosamine for Treatment of Knee Osteoarthritis

NCT03717714 | Completed

• 1 other identifier: Polycan-VN01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of dose of rescue medication (Meloxicam 7.5mg) used in the three groups.

  Through study completion, an average of 12 weeks

Study Arms (3)

Glucosamine 1500mg

ACTIVE COMPARATOR

Glucosamine 1500 mg per day for 12 weeks

Dietary Supplement: Glucosamine 1500 mg

Polycan & Glucosamine 750mg

EXPERIMENTAL

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

Dietary Supplement: Polycan 50mg + Glucosamine 750 mg

Polycan & Glucosamine 1500mg

EXPERIMENTAL

Polycan 50 mg + Glucosamine 1500 mg per day

Dietary Supplement: Polycan 50mg + Glucosamine 1500 mg

Interventions

Glucosamine 1500 mg DIETARY_SUPPLEMENT

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

Glucosamine 1500mg

Polycan 50mg + Glucosamine 750 mg DIETARY_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 & Glucosamine 750mg

Polycan 50mg + Glucosamine 1500 mg DIETARY_SUPPLEMENT

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

Polycan & Glucosamine 1500mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• OA ranging from grade 4 by Kellgren and Lawrence system
• Allergic or contradicted with oral NSAIDs (Meloxicam)
• Pregnant and breastfeeding women.

Sponsors & Collaborators

• Vietstar Biomedical Research: lead

Study Sites (1)

198 Hospital

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Glucosamine

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hexosamines; Amino Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2018
• First Posted: October 24, 2018
• Study Start: April 1, 2017
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: October 24, 2018

Record last verified: 2018-10

Locations

VN (1)