Primary Osteoarthritis of Knee Nos
Conditions
Keywords
Proteoglycan F, knee osteoarthritis, Vietnam
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTProteoglycan F
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.
OTHERPlacebo product
The placebo capsule contained only dextrin powder (Ichimaru Pharcos, Co., Ltd.).
Sponsors
Ichimaru Pharcos, Co., Ltd.
National Geriatric Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The transverse relaxation time (T2) of the cartilage and Classification of other knee injuries | 6 month | Assessed using Magnetic resonance imaging (MRI) of knee |
| Reduce symptoms of knee osteoarthritis 1 | 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 | 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 | 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 | 6 month | Assessed using the Timed Up and Go test |
| Changes of knee joint status | 6 month | The cartilage thickness, Joint fluid thickness, Synovial membrane thickness, was measured using knee ultrasound |
| Pain relief | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum cytokine levels | 6 months | Serum cytokine levels (IL-1β, TNF-α levels) |
| Health related-quality of life | 6 months | Assessed using the EuroQol 5 dimensions 5 levels questionnaires (EQ-5D-5L) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Liver enzymes | 6 months | AST, ALT |
| Kidney function | 6 month | ure, creatinine level |
| Adverse Events | 6 months | Any adverse events will be recorded |
Countries
Vietnam
Outcome results
None listed