Therapeutic Effect of Oral Hyaluronic Acid on Knee Osteoarthritis

NCT ID: NCT07033312

Last Updated: 2025-06-24

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

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-21

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
both the patients and the investigators were blinded to the agent patients took

Study Groups

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oral hyaluronate plus hyaluronate knee injection

oral hyaluronate plus hyaluronate knee injection

Group Type EXPERIMENTAL

oral hyaluronate and injection

Intervention Type DRUG

The patient receives oral hyaluronate and hyaluronate injection

hyaluronate knee injection

hyaluronate knee injection

Group Type PLACEBO_COMPARATOR

hyaluronate injection

Intervention Type DRUG

The patient receives hyaluronate injection only

Interventions

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oral hyaluronate and injection

The patient receives oral hyaluronate and hyaluronate injection

Intervention Type DRUG

hyaluronate injection

The patient receives hyaluronate injection only

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Rheumatological disorders
2. Accidental trauma or fractures involving knees in the past three months
3. Neuropathic pain involving lower limbs
4. Central nervous system disorders including stroke, Parkinsonism, and spinal cord disorders.
5. Depression and cognitive problems
6. Pregnancy
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taichung Veterans General Hospital

Taichung, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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YUAN-YANG CHENG

Role: CONTACT

+886933102763

Facility Contacts

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Jan-Der Wang

Role: primary

886 4 23592525 ext. 4406

References

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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.

Reference Type BACKGROUND
PMID: 24899570 (View on PubMed)

Other Identifiers

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SF22377A

Identifier Type: -

Identifier Source: org_study_id

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