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

Primary Osteoarthritis of Knee Nos Clinical Trial

— Proteoglycan  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04998825
• Other study ID #: NGH001
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: May 30, 2022

Study information

• Verified date: July 2022
• Source: National Geriatric Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 30, 2022
• Est. primary completion date: February 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Primary Osteoarthritis of Knee Nos

Intervention

Dietary Supplement:
• Proteoglycan 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.

Other:
• Placebo product
The placebo capsule contained only dextrin powder (Ichimaru Pharcos, Co., Ltd.).

Locations

Country	Name	City	State
Vietnam	National Geriatric Hospital	Hanoi
Vietnam	National Institution of Nutrition	Hanoi

Sponsors (2)

Lead Sponsor	Collaborator
National Geriatric Hospital	Ichimaru Pharcos, Co., Ltd.

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	Any adverse events will be recorded	6 months
Other	Liver enzymes	AST, ALT	6 months
Other	Kidney function	ure, creatinine level	6 month
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Changes of balance, walking ability and functional mobility	Assessed using the Timed Up and Go test	6 month
Primary	Changes of knee joint status	The cartilage thickness, Joint fluid thickness, Synovial membrane thickness, was measured using knee ultrasound	6 month
Primary	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	Serum cytokine levels	Serum cytokine levels (IL-1ß, TNF-a levels)	6 months
Secondary	Health related-quality of life	Assessed using the EuroQol 5 dimensions 5 levels questionnaires (EQ-5D-5L)	6 months

External Links

•   Efficacy of progressive aquatic resistance training for tibiofemoral cartilage in postmenopausal women with mild knee osteoarthritis: a randomised controlled trial
•   Evaluation of a quantitative measurement of suprapatellar effusion by ultrasonography and its association with symptoms of radiographic knee osteoarthritis: a cross-sectional observational study
•   Whole-Organ Magnetic Resonance Imaging Score (WORMS) of the knee in osteoarthritis