Osteoarthritis of the KneeNCT03717714
Polycan in Combination With Glucosamine for Treatment of Knee Osteoarthritis
A study testing Glucosamine 1500 mg, Polycan 50mg + Glucosamine 750 mg and Polycan 50mg + Glucosamine 1500 mg in people with Osteoarthritis of the Knee, run by Vietstar Biomedical Research at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Glucosamine 1500 mg, Polycan 50mg + Glucosamine 750 mg and Polycan 50mg + Glucosamine 1500 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Apr 2017to 30 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- OA ranging from grade 4 by Kellgren and Lawrence system
- Allergic or contradicted with oral NSAIDs (Meloxicam)
- Pregnant and breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Glucosamine 1500 mg, Polycan 50mg + Glucosamine 750 mg, Polycan 50mg + Glucosamine 1500 mg
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucosamine 1500 mgDietary 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 mgDietary 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 mgDietary supplement
Patients in this group take 3 capsules, each capsule contains Polycan 16.7mg and Glucosamine 500 mg, once a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Glucosamine 1500mg | Active comparator | Glucosamine 1500 mg per day for 12 weeks Receives: Dietary Supplement: Glucosamine 1500 mg |
| Polycan & Glucosamine 750mg | Experimental | Polycan 50 mg + Glucosamine 750 mg per day for 12 weeks Receives: Dietary Supplement: Polycan 50mg + Glucosamine 750 mg |
| Polycan & Glucosamine 1500mg | Experimental | Polycan 50 mg + Glucosamine 1500 mg per day Receives: Dietary Supplement: Polycan 50mg + Glucosamine 1500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to Week 12
Secondary outcomes (1)
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
Measured: Through study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start1 Apr 2017
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vietstar Biomedical Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717714
- Sponsor's protocol ID
- Polycan-VN01
- Status last verified
- Oct 2018
- First submitted
- 20 Oct 2018
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03717714
- Acronym / sponsor ID
- Polycan-VN01
- Conditions
- Osteoarthritis of the Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Vietstar Biomedical ResearchIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 24 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glucosamine 1500mg | Active comparator | Dietary Supplement: Glucosamine 1500 mgGlucosamine 1500 mg per day for 12 weeks |
| Polycan & Glucosamine 750mg | Experimental | Dietary Supplement: Polycan 50mg + Glucosamine 750 mgPolycan 50 mg + Glucosamine 750 mg per day for 12 weeks |
| Polycan & Glucosamine 1500mg | Experimental | Dietary Supplement: Polycan 50mg + Glucosamine 1500 mgPolycan 50 mg + Glucosamine 1500 mg per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- OA ranging from grade 4 by Kellgren and Lawrence system
- Allergic or contradicted with oral NSAIDs (Meloxicam)
- Pregnant and breastfeeding women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucosamine 1500 mgPatients in this group take 3 capsules, each capsule contains Placebo 16.7mg and Glucosamine 500 mg, once a day for 12 weeks | Dietary supplement | Glucosamine 1500mg |
| Polycan 50mg + Glucosamine 750 mgPatients in this group take 3 capsules, each capsule contains Polycan 16.7mg and Glucosamine 250 mg, once a day for 12 weeks | Dietary supplement | Polycan & Glucosamine 750mg |
| Polycan 50mg + Glucosamine 1500 mgPatients in this group take 3 capsules, each capsule contains Polycan 16.7mg and Glucosamine 500 mg, once a day for 12 weeks | Dietary supplement | Polycan & Glucosamine 1500mg |
Primary outcome
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
1 secondary outcome
Number of dose of rescue medication (Meloxicam 7.5mg) used in the three groups.
Time frame: Through study completion, an average of 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucosamine 1500 mg, Polycan 50mg + Glucosamine 750 mg and Polycan 50mg + Glucosamine 1500 mg in people with Osteoarthritis of the Knee, run by Vietstar Biomedical Research at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) changes at 12 weeks in the three groups (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.