Effectiveness of Oral Hyaluronic Acid in Knee Osteoarthritis

NCT ID: NCT04352322

Last Updated: 2020-04-20

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

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-07-31

Brief Summary

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This study was a randomized, double-blind, placebo-controlled study evaluating the efficacy of an oral liquid HA supplement (A+HA) in symptoms relief and improvement of quality of life in knee osteoarthritis patients with mild knee pain.

Detailed Description

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Subjects were initially screened at the Randomization/Baseline Visit (Week 0). Eligible subjects were randomized at the same visit into the treatment period and received the assigned treatment in a double-blind fashion for 8 weeks. During the 8 weeks treatment period, there were three follow-up visits requested (Week 2, Week 4 and Week 8). Efficacy was measured by using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Short Form-36 (SF-36).

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

Study Groups

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A+HA(tm)

20 ml oral solution of hyaluronic acid mixture in combination with glucosamine and chondroitin in a bottle. Administration with 250\~500 ml water under fasting condition in the morning.

Group Type EXPERIMENTAL

A+HA(tm)

Intervention Type DIETARY_SUPPLEMENT

oral solution of hyaluronic acid mixture in combination with glucosamine and chondroitin

Placebo

20 ml oral solution without active ingredients in a bottle. Administration with 250\~500 ml water under fasting condition in the morning.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

oral solution with no active ingredients

Interventions

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A+HA(tm)

oral solution of hyaluronic acid mixture in combination with glucosamine and chondroitin

Intervention Type DIETARY_SUPPLEMENT

Placebo

oral solution with no active ingredients

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Male or female age \>= 40 years old
* Diagnosed with knee OA which met the definition of Ahlbӓck classification12 and had knee joint symptoms within 30 days prior to enrollment

Exclusion Criteria

* Had administered glucosamine one month prior to enrollment
* Had known allergy to oral HA
* BMI ≧40 kg/m2
* Knee OA was caused by occupational hazard or sports injury
* Patients with known other causes of arthritis (infectious rheumatoid or psoriatic arthritis), bony or soft tissue malignancy or peripheral neuropathy involving the lower extremities, cardiopulmonary disease which limited walking more than knee pain, knee instability defined as a report of knee buckling or locking within the past month of the study knee, major neurological deficit that affected gait, psychiatric illness that limited informed consent or Parkinsonism
* Women in pregnancy
* Wheel chair users
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TOP Pharm & Medicalware

UNKNOWN

Sponsor Role collaborator

China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shyu-Jye Wang, MD

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

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TOP Pharm. & Medicalware

Taichung, , Taiwan

Site Status

Countries

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Taiwan

References

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Wang SJ, Wang YH, Huang LC. The effect of oral low molecular weight liquid hyaluronic acid combination with glucosamine and chondroitin on knee osteoarthritis patients with mild knee pain: An 8-week randomized double-blind placebo-controlled trial. Medicine (Baltimore). 2021 Feb 5;100(5):e24252. doi: 10.1097/MD.0000000000024252.

Reference Type DERIVED
PMID: 33592868 (View on PubMed)

Other Identifiers

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DMR101-IRB2-033-1

Identifier Type: -

Identifier Source: org_study_id

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