Effectiveness of Oral Hyaluronic Acid in Knee Osteoarthritis

China Medical University

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Dietary Supplement: Placebo; Dietary Supplement: A+HA(tm)

Study type: Interventional

Funder types: Other

Identifiers

NCT04352322

DMR101-IRB2-033-1

Details and patient eligibility

About

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.

Full 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).

Enrollment: 47 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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47 participants in 2 patient groups, including a placebo group

A+HA(tm)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: A+HA(tm)

Placebo

Placebo Comparator group

Description:

20 ml oral solution without active ingredients in a bottle. Administration with 250\~500 ml water under fasting condition in the morning.

Treatment:

Dietary Supplement: Placebo