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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-05-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Primary Osteoarthritis of Knee Nos

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Proteoglycan F group

* Taking Proteoglycan F
* Dosage of Proteoglycan F: 50mg/day
* Used time: 24 weeks

Group Type EXPERIMENTAL

Proteoglycan F

Intervention Type 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.

Control group

* Taking Placebo (Dextrin)
* Dosage of Placebo: 50mg/day
* Used time: 24 weeks

Group Type PLACEBO_COMPARATOR

Placebo product

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Placebo product

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

Intervention Type OTHER

Other Intervention Names

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PGF Dextrin

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No