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Polycan in Combination With Glucosamine for Treatment of Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717714
Recruitment Status : Completed
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Dietary Supplement: Glucosamine 1500 mg Dietary Supplement: Polycan 50mg + Glucosamine 750 mg Dietary Supplement: Polycan 50mg + Glucosamine 1500 mg Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: Glucosamine 1500mg
Glucosamine 1500 mg per day for 12 weeks
Dietary Supplement: Glucosamine 1500 mg
Patients in this group take 3 capsules, each capsule contains Placebo 16.7mg and Glucosamine 500 mg, once a day for 12 weeks

Experimental: Polycan & Glucosamine 750mg
Polycan 50 mg + Glucosamine 750 mg per day for 12 weeks
Dietary Supplement: Polycan 50mg + Glucosamine 750 mg
Patients in this group take 3 capsules, each capsule contains Polycan 16.7mg and Glucosamine 250 mg, once a day for 12 weeks

Experimental: Polycan & Glucosamine 1500mg
Polycan 50 mg + Glucosamine 1500 mg per day
Dietary Supplement: Polycan 50mg + Glucosamine 1500 mg
Patients in this group take 3 capsules, each capsule contains Polycan 16.7mg and Glucosamine 500 mg, once a day for 12 weeks




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717714


Locations
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Vietnam
198 Hospital
Hanoi, Vietnam
Sponsors and Collaborators
Vietstar Biomedical Research

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Responsible Party: Vietstar Biomedical Research
ClinicalTrials.gov Identifier: NCT03717714    
Other Study ID Numbers: Polycan-VN01
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases