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Completed

NCT Number: NCT03717714

Polycan in Combination With Glucosamine for Treatment of Knee Osteoarthritis

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

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

198 Hospital

Hanoi, Vietnam

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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 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

Primary outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) changes at 12 weeks in the three groups

    Time frame: 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 outcomes

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

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

    Rescue medication (Meloxicam 7.5mg) used by patients for 12 weeks

Sponsors and collaborators

Lead sponsor

Vietstar Biomedical Research

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 24, 2018
Registry last updated
Oct 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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