Polycan in Combination With Glucosamine for Treatment of Knee Osteoarthritis

October 22, 2018 updated by: Vietstar Biomedical Research

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hanoi, Vietnam
        • 198 Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vietstar Biomedical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Actual)

May 30, 2018

Study Completion (Actual)

May 30, 2018

Study Registration Dates

First Submitted

October 20, 2018

First Submitted That Met QC Criteria

October 22, 2018

First Posted (Actual)

October 24, 2018

Study Record Updates

Last Update Posted (Actual)

October 24, 2018

Last Update Submitted That Met QC Criteria

October 22, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Polycan-VN01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe