Efficacy and Tolerability of Proteoglycan F in the Treatment of Knee Osteoarthritis
Condition: Primary Osteoarthritis of Knee Nos
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

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.
    

Intervention name(s): Proteoglycan F; Placebo product
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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.; The placebo capsule contained only dextrin powder (Ichimaru Pharcos, Co., Ltd.).
Other intervention name(s): PGF; Dextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Proteoglycan F; knee osteoarthritis; Vietnam