Effectiveness of Oral Hyaluronic Acid in Knee Osteoarthritis

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

Study Description

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).

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

Taiwan

TOP Pharm. & Medicalware

Taichung, Taiwan

Sponsors and Collaborators

China Medical University Hospital

TOP Pharm & Medicalware

Investigators

• Principal Investigator: Shyu-Jye Wang, MD; China Medical University Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: China Medical University Hospital
• ClinicalTrials.gov Identifier: NCT04352322
• Other Study ID Numbers: DMR101-IRB2-033-1
• First Posted: April 20, 2020
• 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

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases