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

NCT04998825 | Completed DMC

• 1 other identifier: NGH001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Primary Osteoarthritis of Knee Nos

Keywords

Proteoglycan F; knee osteoarthritis; Vietnam

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Serum cytokine levels

  6 months

• Health related-quality of life

  6 months

Other Outcomes (3)

• Adverse Events

  6 months

• Liver enzymes

  6 months

• Kidney function

  6 month

Study Arms (2)

Proteoglycan F group

EXPERIMENTAL

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

Dietary Supplement: Proteoglycan F

Control group

PLACEBO COMPARATOR

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

Other: Placebo product

Interventions

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.

Also known as: PGF

Proteoglycan F group

Placebo product OTHER

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

Also known as: Dextrin

Control group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Geriatric Hospital: lead
• Ichimaru Pharcos, Co., Ltd.: collaborator

Study Sites (2)

National Geriatric Hospital

Hanoi, 100000, Vietnam

Location

National Institution of Nutrition

Hanoi, 100000, Vietnam

Location

Related 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

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Prostaglandins F; Dextrins

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Anh T Nguyen, PhD

  National Geriatric Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: August 10, 2021
• Study Start: August 1, 2021
• Primary Completion: February 25, 2022
• Study Completion: May 30, 2022
• Last Updated: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)