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OpenTrials
Completed

NCT Number: NCT04352322

Effectiveness of Oral Hyaluronic Acid in Knee Osteoarthritis

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TOP Pharm. & Medicalware

Taichung, Taiwan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A+HA(tm)

Dietary Supplement

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

Placebo

Dietary Supplement

oral solution with no active ingredients

Primary outcomes

  1. WOMAC

    Time frame: 8 weeks

    Mean change from baseline to 8 weeks. The higher the score, the greater the severity.

Secondary outcomes

  1. SF-36

    Time frame: 8 weeks

    Mean change from baseline to 8 weeks. A higher score indicates a better QoL.

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Collaborators

  • TOP Pharm & Medicalware

Registry information

Official study title

Effectiveness of Oral Hyaluronic Acid (A+ HA(tm), TOP Pharm.) in Knee Osteoarthritis: Clinical Trial

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 20, 2020
Registry last updated
Apr 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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