Therapeutic Effect of Oral Hyaluronic Acid on Knee Osteoarthritis

NCT07033312 | Completed DMC

• 1 other identifier: SF22377A
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the effect of oral hyaluronate in patients with knee osteoarthritis. The main question it aims to answer is: the therapeutic effect in the combined treatment of oral nutritional supplement based on hyaluronic acid with hyaluronic acid intra-articular Injection on symptomatic knee osteoarthritis. Researchers will compare it to those who receive only hyaluronic acid injection to see if the combined treatment is better. Participants will receive a total of three months of oral hyaluronate or placebo agents.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  The Western Ontario and McMaster Universities Arthritis Index (WOMAC) aim to reveal pain, stiffness and function of the knee, the minimum and maximum values are 0 and 68, and a higher score mean a worse outcome.

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (2)

• knee strength

  From enrollment to the end of treatment at 12 weeks

• Timed up and go test

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

oral hyaluronate plus hyaluronate knee injection

EXPERIMENTAL

oral hyaluronate plus hyaluronate knee injection

Drug: oral hyaluronate and injection

hyaluronate knee injection

PLACEBO COMPARATOR

hyaluronate knee injection

Drug: hyaluronate injection

Interventions

hyaluronate injection DRUG

The patient receives hyaluronate injection only

hyaluronate knee injection

oral hyaluronate and injection DRUG

The patient receives oral hyaluronate and hyaluronate injection

oral hyaluronate plus hyaluronate knee injection

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Radiological evidence of osteoarthritis Ahlbäck stage I-III.
• Had knee effusion at the suprapatellar recess under ultrasonographic examination.
• Age between 60 and 75 years old.

You may not qualify if:

• Rheumatological disorders
• Accidental trauma or fractures involving knees in the past three months
• Neuropathic pain involving lower limbs
• Central nervous system disorders including stroke, Parkinsonism, and spinal cord disorders.
• Depression and cognitive problems
• Pregnancy

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan, 40705, Taiwan

Location

Related Publications (1)

• Nelson FR, Zvirbulis RA, Zonca B, Li KW, Turner SM, Pasierb M, Wilton P, Martinez-Puig D, Wu W. The effects of an oral preparation containing hyaluronic acid (Oralvisc(R)) on obese knee osteoarthritis patients determined by pain, function, bradykinin, leptin, inflammatory cytokines, and heavy water analyses. Rheumatol Int. 2015 Jan;35(1):43-52. doi: 10.1007/s00296-014-3047-6. Epub 2014 Jun 5.

  PMID: 24899570 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Injections

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: both the patients and the investigators were blinded to the agent patients took
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2025
• First Posted: June 24, 2025
• Study Start: April 21, 2023
• Primary Completion: February 17, 2025
• Study Completion: February 17, 2025
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)