Effectiveness of Oral Hyaluronic Acid in Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Dietary Supplement: A+HA(tm); Dietary Supplement: Placebo

• Registration Number: NCT04352322
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-01
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2020-04
• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-16
• Last Update Submitted: 2020-04-16
• Study First Posted: 2020-04-20
• Last Update Posted: 2020-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A+HA(tm)	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.
Placebo	Placebo	20 ml oral solution without active ingredients in a bottle. Administration with 250\~500 ml water under fasting condition in the morning.

Primary Outcome Measures

Name	Time	Method
WOMAC	8 weeks	Mean change from baseline to 8 weeks. The higher the score, the greater the severity.

Secondary Outcome Measures

Name	Time	Method
SF-36	8 weeks	Mean change from baseline to 8 weeks. A higher score indicates a better QoL.

Trial Locations

Locations (1)

TOP Pharm. & Medicalware; 🇨🇳 Taichung, Taiwan