Research on Efficacy and Tolerability of Proteoglycan F in the Treatment of Knee Osteoarthritis: a Prospective, Randomized, Double-blind Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 72
- Locations
- 2
- Primary Endpoint
- Changes of knee joint status
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Proteoglycan F group
- Taking Proteoglycan F
- Dosage of Proteoglycan F: 50mg/day
- Used time: 24 weeks
Intervention: Proteoglycan F (Dietary Supplement)
Control group
- Taking Placebo (Dextrin)
- Dosage of Placebo: 50mg/day
- Used time: 24 weeks
Intervention: Placebo product (Other)
Outcomes
Primary Outcomes
Changes of knee joint status
Time Frame: 6 month
The cartilage thickness, Joint fluid thickness, Synovial membrane thickness, was measured using knee ultrasound
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)
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
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
Changes of balance, walking ability and functional mobility
Time Frame: 6 month
Assessed using the Timed Up and Go test
Secondary Outcomes
- Serum cytokine levels(6 months)
- Health related-quality of life(6 months)
Investigators
Nguyen Trung Anh
Director
National Geriatric Hospital