NCT04212741

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blinded, placebo-controlled, randomized trial to assess the efficacy of oral solution of hyaluronic acid mixture (A+ HA(tm)). During 8 weeks treatment period, there were three follow-up visits requested (Week 2, Week 4 and Week 8).

Detailed description

Subjects were initially screened at the Randomization/Baseline Visit (Week 0). Eligible subjects were randomized at the same visit into treatment period, and received the assigned treatment in a double-blind fashion for 8 weeks. Efficacy was measured by the several questionnaire including Knee injury and Osteoarthritis (KOOS), the Short Form-36 (SF-36) and Pittsburgh Sleep Quality Index (CPSQI) for each visit. Incidences of adverse events (AEs) were monitored for each subject once the subject had received 1 dose of study medication; the incidence of serious AEs (SAEs) were monitored for each subject once the subject had signed the informed consent through to the End-of-Study or ET Visit. Vital signs were measured at baseline and End-of-Study or ET Visit.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	A+ HA(tm)	oral solution of hyaluronic acid mixture
DIETARY_SUPPLEMENT	Placebo	oral solution with no-active ingredients

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2019-12-30
• Last updated: 2020-01-03

Locations

1 site across 1 country: Taiwan