Effectiveness of Oral Hyaluronic Acid in Knee Osteoarthritis

NCT04352322 | Completed

• 1 other identifier: DMR101-IRB2-033-1
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• WOMAC

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

  8 weeks

Secondary Outcomes (1)

• SF-36

  8 weeks

Study Arms (2)

A+HA(tm)

EXPERIMENTAL

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)

Placebo

PLACEBO COMPARATOR

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

Interventions

A+HA(tm) DIETARY_SUPPLEMENT

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

A+HA(tm)

Placebo DIETARY_SUPPLEMENT

oral solution with no active ingredients

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead
• TOP Pharm & Medicalware: collaborator

Study Sites (1)

TOP Pharm. & Medicalware

Taichung, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 33592868 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Shyu-Jye Wang, MD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 20, 2020
• Study Start: January 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)