Efficacy and Tolerability of Proteoglycan F in the Treatment of Knee Osteoarthritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Research on Efficacy and Tolerability of Proteoglycan F in the Treatment of Knee Osteoarthritis: a Prospective, Randomized, Double-blind Controlled Trial

Conditions
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Primary Osteoarthritis of Knee Nos

Intervention / Treatment
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* Dietary Supplement: Proteoglycan F
* Other: Placebo product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proteoglycan F group<br>Taking Proteoglycan F Dosage of Proteoglycan F: 50mg/day Used time: 24 weeks | Dietary Supplement: Proteoglycan F<br>* 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.<br>* Other names: PGF;|
| Placebo Comparator: Control group<br>Taking Placebo (Dextrin) Dosage of Placebo: 50mg/day Used time: 24 weeks | Other: Placebo product<br>* The placebo capsule contained only dextrin powder (Ichimaru Pharcos, Co., Ltd.).<br>* Other names: Dextrin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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) | 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) | 6 month | 
| Changes of balance, walking ability and functional mobility | Assessed using the Timed Up and Go test | 6 month | 
| Changes of knee joint status | The cartilage thickness, Joint fluid thickness, Synovial membrane thickness, was measured using knee ultrasound | 6 month | 
| The transverse relaxation time (T2) of the cartilage and Classification of other knee injuries | Assessed using Magnetic resonance imaging (MRI) of knee | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum cytokine levels | Serum cytokine levels (IL-1β, TNF-α levels) | 6 months | 
| Health related-quality of life | Assessed using the EuroQol 5 dimensions 5 levels questionnaires (EQ-5D-5L) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proteoglycan F, knee osteoarthritis, Vietnam