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NCT Number: NCT04998825

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

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Geriatric Hospital, Hanoi, Vietnam

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Proteoglycan F

Dietary Supplement

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 names: PGF

Placebo product

Other

The placebo capsule contained only dextrin powder (Ichimaru Pharcos, Co., Ltd.).

Other names: Dextrin

Primary outcomes

  1. 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

  2. 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.

  3. 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)

  4. 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)

  5. Changes of balance, walking ability and functional mobility

    Time frame: 6 month

    Assessed using the Timed Up and Go test

  6. Changes of knee joint status

    Time frame: 6 month

    The cartilage thickness, Joint fluid thickness, Synovial membrane thickness, was measured using knee ultrasound

  7. 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

Secondary outcomes

  1. Serum cytokine levels

    Time frame: 6 months

    Serum cytokine levels (IL-1β, TNF-α levels)

  2. Health related-quality of life

    Time frame: 6 months

    Assessed using the EuroQol 5 dimensions 5 levels questionnaires (EQ-5D-5L)

Other outcomes

  1. Adverse Events

    Time frame: 6 months

    Any adverse events will be recorded

  2. Liver enzymes

    Time frame: 6 months

    AST, ALT

  3. Kidney function

    Time frame: 6 month

    ure, creatinine level

Sponsors and collaborators

Lead sponsor

National Geriatric Hospital

Other Gov

Collaborators

  • Ichimaru Pharcos, Co., Ltd.

Registry information

Official study title

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

Acronym: Proteoglycan

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 10, 2021
Registry last updated
Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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