Effectiveness of Oral Hyaluronic Acid in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Effectiveness of Oral Hyaluronic Acid (A+ HA(tm), TOP Pharm.) in Knee Osteoarthritis: Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04352322
• Other study ID #: DMR101-IRB2-033-1
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: July 2016

Study information

• Verified date: April 2020
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Male or female age >= 40 years old

• Diagnosed with knee OA which met the definition of Ahlb?ck 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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Dietary Supplement:
• A+HA(tm)
oral solution of hyaluronic acid mixture in combination with glucosamine and chondroitin
• Placebo
oral solution with no active ingredients

Locations

Country	Name	City	State
Taiwan	TOP Pharm. & Medicalware	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
China Medical University Hospital	TOP Pharm & Medicalware

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC	Mean change from baseline to 8 weeks. The higher the score, the greater the severity.	8 weeks
Secondary	SF-36	Mean change from baseline to 8 weeks. A higher score indicates a better QoL.	8 weeks