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Polycan in Combination With Glucosamine for Treatment of Knee Osteoarthritis

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Glucosamine 1500 mg
Polycan 50mg + Glucosamine 750 mg
Polycan 50mg + Glucosamine 1500 mg
Sponsored by
Vietstar Biomedical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • 198 Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Glucosamine 1500mg

Polycan & Glucosamine 750mg

Polycan & Glucosamine 1500mg

Arm Description

Glucosamine 1500 mg per day for 12 weeks

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

Polycan 50 mg + Glucosamine 1500 mg per day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of dose of rescue medication (Meloxicam 7.5mg) used in the three groups.
Rescue medication (Meloxicam 7.5mg) used by patients for 12 weeks

Full Information

First Posted
October 20, 2018
Last Updated
October 22, 2018
Sponsor
Vietstar Biomedical Research
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1. Study Identification

Unique Protocol Identification Number
NCT03717714
Brief Title
Polycan in Combination With Glucosamine for Treatment of Knee Osteoarthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
May 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vietstar Biomedical Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucosamine 1500mg
Arm Type
Active Comparator
Arm Description
Glucosamine 1500 mg per day for 12 weeks
Arm Title
Polycan & Glucosamine 750mg
Arm Type
Experimental
Arm Description
Polycan 50 mg + Glucosamine 750 mg per day for 12 weeks
Arm Title
Polycan & Glucosamine 1500mg
Arm Type
Experimental
Arm Description
Polycan 50 mg + Glucosamine 1500 mg per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucosamine 1500 mg
Intervention Description
Patients in this group take 3 capsules, each capsule contains Placebo 16.7mg and Glucosamine 500 mg, once a day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Polycan 50mg + Glucosamine 750 mg
Intervention Description
Patients in this group take 3 capsules, each capsule contains Polycan 16.7mg and Glucosamine 250 mg, once a day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Polycan 50mg + Glucosamine 1500 mg
Intervention Description
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 Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) changes at 12 weeks in the three groups
Description
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
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Number of dose of rescue medication (Meloxicam 7.5mg) used in the three groups.
Description
Rescue medication (Meloxicam 7.5mg) used by patients for 12 weeks
Time Frame
Through study completion, an average of 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
198 Hospital
City
Hanoi
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Polycan in Combination With Glucosamine for Treatment of Knee Osteoarthritis

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