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Effectiveness of Oral Hyaluronic Acid in Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT04352322
Recruitment Status : Completed
First Posted : April 20, 2020
Last Update Posted : April 20, 2020
Sponsor:
Collaborator:
TOP Pharm & Medicalware
Information provided by (Responsible Party):
China Medical University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Dietary Supplement: A+HA(tm) Dietary Supplement: Placebo Not Applicable

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Oral Hyaluronic Acid (A+ HA(tm), TOP Pharm.) in Knee Osteoarthritis: Clinical Trial
Actual Study Start Date : January 2012
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: 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.
Dietary Supplement: A+HA(tm)
oral solution of hyaluronic acid mixture in combination with glucosamine and chondroitin

Placebo Comparator: Placebo
20 ml oral solution without active ingredients in a bottle. Administration with 250~500 ml water under fasting condition in the morning.
Dietary Supplement: Placebo
oral solution with no active ingredients




Primary Outcome Measures :
  1. WOMAC [ Time Frame: 8 weeks ]
    Mean change from baseline to 8 weeks. The higher the score, the greater the severity.


Secondary Outcome Measures :
  1. SF-36 [ Time Frame: 8 weeks ]
    Mean change from baseline to 8 weeks. A higher score indicates a better QoL.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04352322


Locations
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Taiwan
TOP Pharm. & Medicalware
Taichung, Taiwan
Sponsors and Collaborators
China Medical University Hospital
TOP Pharm & Medicalware
Investigators
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Principal Investigator: Shyu-Jye Wang, MD China Medical University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT04352322    
Other Study ID Numbers: DMR101-IRB2-033-1
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases