Polycan in Combination With Glucosamine for Treatment of Knee Osteoarthritis

NCT ID: NCT03717714

Last Updated: 2018-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2018-05-30

Brief Summary

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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

Detailed Description

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Conditions

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Osteoarthritis of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Glucosamine 1500mg

Glucosamine 1500 mg per day for 12 weeks

Group Type ACTIVE_COMPARATOR

Glucosamine 1500 mg

Intervention Type 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 & Glucosamine 750mg

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

Group Type EXPERIMENTAL

Polycan 50mg + Glucosamine 750 mg

Intervention Type 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 1500mg

Polycan 50 mg + Glucosamine 1500 mg per day

Group Type EXPERIMENTAL

Polycan 50mg + Glucosamine 1500 mg

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vietstar Biomedical Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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198 Hospital

Hanoi, , Vietnam

Site Status

Countries

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Vietnam

Other Identifiers

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Polycan-VN01

Identifier Type: -

Identifier Source: org_study_id

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