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

NCT04998825 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2022-07-13

No results posted yet for this study

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

Interventions

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

Placebo product

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

Sponsors & Collaborators

  • Ichimaru Pharcos, Co., Ltd.

    collaborator UNKNOWN

  • National Geriatric Hospital

    lead OTHER_GOV

Principal Investigators

  • Anh T Nguyen, PhD · National Geriatric Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2022-02-25
Completion
2022-05-30

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04998825 on ClinicalTrials.gov