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

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.
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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.
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Dietary Supplement: Placebo
oral solution with no active ingredients |
- WOMAC [ Time Frame: 8 weeks ]Mean change from baseline to 8 weeks. The higher the score, the greater the severity.
- SF-36 [ Time Frame: 8 weeks ]Mean change from baseline to 8 weeks. A higher score indicates a better QoL.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Taiwan | |
TOP Pharm. & Medicalware | |
Taichung, Taiwan |
Principal Investigator: | Shyu-Jye Wang, MD | China Medical University Hospital |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |