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

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Osteoarthritis of Knee Nos
• Intervention / Treatment: Dietary supplement: Proteoglycan F; Other: Placebo product

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam, 100000
    • National Geriatric Hospital
  • Hanoi, Vietnam, 100000
    • National Institution of Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Proteoglycan F group; Taking Proteoglycan F; Dosage of Proteoglycan F: 50mg/day; Used time: 24 weeks	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 Names: PGF
Placebo Comparator: Control group; Taking Placebo (Dextrin); Dosage of Placebo: 50mg/day; Used time: 24 weeks	Other: Placebo product; The placebo capsule contained only dextrin powder (Ichimaru Pharcos, Co., Ltd.).; Other Names: Dextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Changes of balance, walking ability and functional mobility	Assessed using the Timed Up and Go test	6 month
Changes of knee joint status	The cartilage thickness, Joint fluid thickness, Synovial membrane thickness, was measured using knee ultrasound	6 month
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum cytokine levels	Serum cytokine levels (IL-1β, TNF-α levels)	6 months
Health related-quality of life	Assessed using the EuroQol 5 dimensions 5 levels questionnaires (EQ-5D-5L)	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Any adverse events will be recorded	6 months
Liver enzymes	AST, ALT	6 months
Kidney function	ure, creatinine level	6 month

Collaborators and Investigators

• Sponsor: National Geriatric Hospital
• Collaborators: Ichimaru Pharcos, Co., Ltd.
• Investigators: Principal Investigator: Anh T Nguyen, PhD, National Geriatric Hospital

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): February 25, 2022
• Study Completion (Actual): May 30, 2022

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 10, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: knee osteoarthritis; Vietnam; Proteoglycan F
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: NGH001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

Will individual participant data be available (including data dictionaries)?

• Yes

What data in particular will be shared?

->Individual participant data that underlie the results reported in this article, after deidentification (text, tables,figures, and appendices).

What other documents will be available?

-> Study Protocol

When will data be available (start and end dates)? --> Beginning 9 months and ending 36 months following article publication.

With whom?

-> Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

For what types of analyses?

-> For individual participant data meta-analysis

By what mechanism will data be made available?

-> Not applicable

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No