Primary Osteoarthritis of Knee NosProteoglycanNCT04998825
Efficacy and Tolerability of Proteoglycan F in the Treatment of Knee Osteoarthritis
A study testing Proteoglycan F in people with Primary Osteoarthritis of Knee Nos, run by National Geriatric Hospital at 2 sites in Vietnam.
Trial summary
This clinical trial study is conducted in Vietnam to assess the efficacy and tolerability of Proteoglycan F in the treatment of primary knee osteoarthritis. 72 outpatients (40-80 years old) were diagnosed with primary knee osteoarthritis and met the American College of Rheumatology 1991 criteria. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Primary Osteoarthritis of Knee Nos
- What is being tested?
- Proteoglycan F
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesVietnam
- Study dates
- 1 Aug 2021to 30 May 2022
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40-80 years old
- Diagnosed with primary knee osteoarthritis and met the American College of Rheumatology 1991 criteria
- Patients have to be symptomatic for ≥ 3 months before enrollment
- Have a radiologic grade II and III measured by the Kellgren-Lawrence criteria
Who cannot join
- Patients with secondary knee osteoarthritis
- Patients with grade-I and IV osteoarthritis (Kellgren-Lawrence)
- Patients having joint lavage, arthroscopy, or treatment with hyaluronic acid or other disease modifying agents during the previous 6 months, or treated with intra-articular corticosteroids during the past 3 months, will be excluded from the study.
- Patients have contraindications to Non-Steroidal Anti-Inflammatory Drugs
- Patients have hematologic disorders, renal disease, liver disease, diabetes mellitus, acute illness, other rheumatic diseases, disabling comorbid conditions that would make it impossible for the patient to visit the research center.
- Pregnancy.
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
National Geriatric Hospital
Hanoi, 100000
National Institution of Nutrition
Hanoi, 100000
About this study
Official title: Research on Efficacy and Tolerability of Proteoglycan F in the Treatment of Knee Osteoarthritis: a Prospective, Randomized, Double-blind Controlled Trial
This clinical trial study is conducted in Vietnam to assess the efficacy and tolerability of Proteoglycan F in the treatment of primary knee osteoarthritis. 72 outpatients (40-80 years old) were diagnosed with primary knee osteoarthritis and met the American College of Rheumatology 1991 criteria. Patients have to be symptomatic for ≥ 3 months before enrollment and have a radiologic grade II and III measured by the Kellgren-Lawrence criteria. The study was designed as a Prospective, Randomized, Double-blind Controlled trial. Each patient will be follow during 24 weeks of intervention, follow-up every 4 weeks.
Read the detailed description
With the trend of aging population and progressive increment of obesity in Vietnam, the number of patients suffering from osteoarthritis most likely will substantially increase in the coming years. Therefore, it is necessary to having a suitable and effective approach of treatment for osteoarthritis by using functional foods.
Proteoglycan is the basic substance of articular cartilage. Proteoglycans are mostly found in the extracellular matrix of animal tissue as cartilage, or in the blood vessels and brain. These substances are a key ingredient in the regeneration of cartilage, inhibiting the enzyme elastase - an intermediate that causes degenerative articular cartilage and reduces the formation of free oxygen radicals in cartilage tissue. Therefore, the effects are on inhibiting cartilage calcification, regenerating cartilage and relieving pain for cartilage degeneration, promoting cartilage metabolism, forming cartilage.
Previous studies have demonstrated that proteoglycan enhances fluid not only to alleviate arthritis pain but also prevent complications, as it gradually overcomes the damage of joint bone, resolves inflammation, helps relieve pain and prevent osteoarthritis, osteoporosis effectively. Otherwise, industrially extracted Proteoglycans presents to be safe and valuable for future studies of its function. Therefore, this randomized, double-blind controlled trial is conducted in Vietnam to assess the efficacy and tolerability of Proteoglycan F in the treatment of primary knee osteoarthritis.
- Conditions
- Primary Osteoarthritis of Knee Nos
- Being tested
- Proteoglycan F, Placebo product
- Keywords
- Proteoglycan F, knee osteoarthritis, Vietnam
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proteoglycan FDietary supplement
Also called PGF
Salmon proteoglycan (Proteoglycan F) was extracted from salmon (Oncorhynchus keta) nasal cartilage. Salmon cartilage PG (Proteoglycan F) was manufactured in the form of a hard capsule by Ichimaru Pharcos, Co., Ltd. (at 318-1 Asagi, Motosu-shi, Gifu 501-0475 Japan) and consisted of 50 mg proteoglycan.
Placebo productOther
Also called Dextrin
The placebo capsule contained only dextrin powder (Ichimaru Pharcos, Co., Ltd.).
| Study group | Role | What they receive |
|---|---|---|
| Proteoglycan F group | Experimental | * Taking Proteoglycan F
* Dosage of Proteoglycan F: 50mg/day
* Used time: 24 weeks Receives: Dietary Supplement: Proteoglycan F |
| Control group | Placebo comparator | * Taking Placebo (Dextrin)
* Dosage of Placebo: 50mg/day
* Used time: 24 weeks Receives: Other: Placebo product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Pain intensity was assessed using the Numeric Rating Scale. Scores range from 0 to 10. The higher the score, the more severe the pain
Measured: 6 month
Reduce symptoms of knee osteoarthritis 1
Symptoms (pain, functionality and joints stiffness) were assessed using the Knee injury and Osteoarthritis Outcome Score. The five patient-relevant subscales of KOOS are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic assessment scales and generic measures.
Measured: 6 month
Reduce symptoms of knee osteoarthritis 2
Symptoms (pain, functionality and joints stiffness) were assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS), Symptoms (pain, functionality and joints stiffness) were assessed using the Lequesne index. The Lequesne index has an interview format questionnaire, including 10 questions divided into three sections regarding pain, maximum distance walked and activities of daily living. The score ranges from 0 (no pain, no disability) to 24 (maximum pain and disability)
Measured: 6 month
Reduce symptoms of knee osteoarthritis 3
Symptoms (pain, functionality and joints stiffness) were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index. Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68)
Measured: 6 month
Changes of balance, walking ability and functional mobility
Assessed using the Timed Up and Go test
Measured: 6 month
Changes of knee joint status
The cartilage thickness, Joint fluid thickness, Synovial membrane thickness, was measured using knee ultrasound
Measured: 6 month
The transverse relaxation time (T2) of the cartilage and Classification of other knee injuries
Assessed using Magnetic resonance imaging (MRI) of knee
Measured: 6 month
Secondary outcomes (2)
Serum cytokine levels
Serum cytokine levels (IL-1β, TNF-α levels)
Measured: 6 months
Health related-quality of life
Assessed using the EuroQol 5 dimensions 5 levels questionnaires (EQ-5D-5L)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start1 Aug 2021
- Primary completion25 Feb 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Osteoarthritis of Knee NosStudies 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Geriatric Hospital
- Sponsor type
- Other government
- Collaborators
- Ichimaru Pharcos, Co., Ltd.
- Responsible party
- Principal investigator, Nguyen Trung Anh, National Geriatric Hospital
- Investigators
- Anh T Nguyen, PhD, Principal investigator, National Geriatric Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998825
- Sponsor's protocol ID
- NGH001
- Acronym
- Proteoglycan
- Status last verified
- Jul 2022
- First submitted
- 15 Jun 2021
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will individual participant data be available (including data dictionaries)? * Yes What data in particular will be shared? -\>Individual participant data that underlie the results reported in this article, after deidentification (text, tables,figures, and appendices). What other documents will be available? -\> Study Protocol When will data be available (start and end dates)? --\> Beginning 9 months and ending 36 months following article publication. With whom? -\> Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. For what types of analyses? -\> For individual participant data meta-analysis By what mechanism will data be made available? -\> Not applicable
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Efficacy and Tolerability of Proteoglycan F in the Treatment of Knee Osteoarthritis: a Prospective, Randomized, Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT04998825
- Acronym / sponsor ID
- Proteoglycan / NGH001
- Conditions
- Primary Osteoarthritis of Knee Nos
- Keywords
- Proteoglycan F, knee osteoarthritis, Vietnam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- National Geriatric HospitalOther government
- Collaborators
- Ichimaru Pharcos, Co., Ltd.
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 10 Aug 2021 (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.
This clinical trial study is conducted in Vietnam to assess the efficacy and tolerability of Proteoglycan F in the treatment of primary knee osteoarthritis. 72 outpatients (40-80 years old) were diagnosed with primary knee osteoarthritis and met the American College of Rheumatology 1991 criteria. Patients have to be symptomatic for ≥ 3 months before enrollment and have a radiologic grade II and III measured by the Kellgren-Lawrence criteria. The study was designed as a Prospective, Randomized, Double-blind Controlled trial. Each patient will be follow during 24 weeks of intervention, follow-up every 4 weeks.
Detailed description
With the trend of aging population and progressive increment of obesity in Vietnam, the number of patients suffering from osteoarthritis most likely will substantially increase in the coming years. Therefore, it is necessary to having a suitable and effective approach of treatment for osteoarthritis by using functional foods.
Proteoglycan is the basic substance of articular cartilage. Proteoglycans are mostly found in the extracellular matrix of animal tissue as cartilage, or in the blood vessels and brain. These substances are a key ingredient in the regeneration of cartilage, inhibiting the enzyme elastase - an intermediate that causes degenerative articular cartilage and reduces the formation of free oxygen radicals in cartilage tissue. Therefore, the effects are on inhibiting cartilage calcification, regenerating cartilage and relieving pain for cartilage degeneration, promoting cartilage metabolism, forming cartilage.
Previous studies have demonstrated that proteoglycan enhances fluid not only to alleviate arthritis pain but also prevent complications, as it gradually overcomes the damage of joint bone, resolves inflammation, helps relieve pain and prevent osteoarthritis, osteoporosis effectively. Otherwise, industrially extracted Proteoglycans presents to be safe and valuable for future studies of its function. Therefore, this randomized, double-blind controlled trial is conducted in Vietnam to assess the efficacy and tolerability of Proteoglycan F in the treatment of primary knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proteoglycan F group | Experimental | Dietary Supplement: Proteoglycan F* Taking Proteoglycan F * Dosage of Proteoglycan F: 50mg/day * Used time: 24 weeks |
| Control group | Placebo comparator | Other: Placebo product* Taking Placebo (Dextrin) * Dosage of Placebo: 50mg/day * Used time: 24 weeks |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 40-80 years old
- Diagnosed with primary knee osteoarthritis and met the American College of Rheumatology 1991 criteria
- Patients have to be symptomatic for ≥ 3 months before enrollment
- Have a radiologic grade II and III measured by the Kellgren-Lawrence criteria
Key exclusion criteria (6 listed)
- Patients with secondary knee osteoarthritis
- Patients with grade-I and IV osteoarthritis (Kellgren-Lawrence)
- Patients having joint lavage, arthroscopy, or treatment with hyaluronic acid or other disease modifying agents during the previous 6 months, or treated with intra-articular corticosteroids during the past 3 months, will be excluded from the study.
- Patients have contraindications to Non-Steroidal Anti-Inflammatory Drugs
- Patients have hematologic disorders, renal disease, liver disease, diabetes mellitus, acute illness, other rheumatic diseases, disabling comorbid conditions that would make it impossible for the patient to visit the research center.
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 |
|---|---|---|
| Proteoglycan FAlso: PGFSalmon proteoglycan (Proteoglycan F) was extracted from salmon (Oncorhynchus keta) nasal cartilage. Salmon cartilage PG (Proteoglycan F) was manufactured in the form of a hard capsule by Ichimaru Pharcos, Co., Ltd. (at 318-1 Asagi, Motosu-shi, Gifu 501-0475 Japan) and consisted of 50 mg proteoglycan. | Dietary supplement | Proteoglycan F group |
| Placebo productAlso: DextrinThe placebo capsule contained only dextrin powder (Ichimaru Pharcos, Co., Ltd.). | Other | Control group |
Primary outcome
Pain relief
Time frame: 6 month
Pain intensity was assessed using the Numeric Rating Scale. Scores range from 0 to 10. The higher the score, the more severe the pain
Reduce symptoms of knee osteoarthritis 1
Time frame: 6 month
Symptoms (pain, functionality and joints stiffness) were assessed using the Knee injury and Osteoarthritis Outcome Score. The five patient-relevant subscales of KOOS are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic assessment scales and generic measures.
Reduce symptoms of knee osteoarthritis 2
Time frame: 6 month
Symptoms (pain, functionality and joints stiffness) were assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS), Symptoms (pain, functionality and joints stiffness) were assessed using the Lequesne index. The Lequesne index has an interview format questionnaire, including 10 questions divided into three sections regarding pain, maximum distance walked and activities of daily living. The score ranges from 0 (no pain, no disability) to 24 (maximum pain and disability)
Reduce symptoms of knee osteoarthritis 3
Time frame: 6 month
Symptoms (pain, functionality and joints stiffness) were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index. Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68)
Changes of balance, walking ability and functional mobility
Time frame: 6 month
Assessed using the Timed Up and Go test
Changes of knee joint status
Time frame: 6 month
The cartilage thickness, Joint fluid thickness, Synovial membrane thickness, was measured using knee ultrasound
The transverse relaxation time (T2) of the cartilage and Classification of other knee injuries
Time frame: 6 month
Assessed using Magnetic resonance imaging (MRI) of knee
2 secondary outcomes
Serum cytokine levels
Time frame: 6 months
Health related-quality of life
Time frame: 6 months
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 13 Jul 2022.
- Whole-Organ Magnetic Resonance Imaging Score (WORMS) of the knee in osteoarthritisLink provided by the sponsor.
- Evaluation of a quantitative measurement of suprapatellar effusion by ultrasonography and its association with symptoms of radiographic knee osteoarthritis: a cross-sectional observational studyLink provided by the sponsor.
- Efficacy of progressive aquatic resistance training for tibiofemoral cartilage in postmenopausal women with mild knee osteoarthritis: a randomised controlled trialLink provided by the sponsor.
- Individual participant dataSharing planned: No. Will individual participant data be available (including data dictionaries)? * Yes What data in particular will be shared? ->Individual participant data that underlie the results reported in this article, after deidentification (text, tables,figures, and appendices). What other documents will be available? -> Study Protocol When will data be available (start and end dates)? --> Beginning 9 months and ending 36 months following article publication. With whom? -> Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. For what types of analyses? -> For individual participant data meta-analysis By what mechanism will data be made available? -> Not applicable
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.
Anh T Nguyen, PhD principal investigator
National Geriatric Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proteoglycan F in people with Primary Osteoarthritis of Knee Nos, run by National Geriatric Hospital at 2 sites 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 4 inclusion and 6 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 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Pain relief (time frame: 6 month). The study lists 7 primary outcomes in all. 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 13 Jul 2022.