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

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).

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Dietary supplement: A+ HA(tm); Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • TOP Pharm. & Medicalware

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age >= 40 years old
2. Male or Female
3. With osteoarthritis of the knee based on the definition of Ahlback 1968 and with significant symptoms within 30 days before enrollment.
4. No limitation for use of concomitant medication

Exclusion Criteria:

1. Use of Glucosamine within 1 month before enrollment
2. Osteoarthritis of the knee due to exercise or occupational injury
3. Allergy with Oral Hyaluronic Acid
4. Bilateral Total Knee Replacement
5. Pregnant
6. Need use wheelchairs
7. BMI≥40
8. With at least one condition: Known other causes of arthritis (infectious arthritis, rheumatoid arthritis, connective tissue disease, gout, pseudogout, or psoriatic arthritis), bony or soft tissue malignancy or skin lesions or peripheral neuropathy involving the lower extremities, cardiopulmonary disease which limits walking more than knee pain. Knee instability defined as report of knee bucking or locking within the past month of the study knee, major neurologic deficit that affects gait, psychiatric illness that limits informed consent, and parkinsonism.
9. Cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 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; oral solution with no-active ingredients
Experimental: A+ HA(tm); 20 ml oral solution of hyaluronic acid mixture in a bottle. Administration with 250~500 ml water under fasting condition in the morning.	Dietary supplement: A+ HA(tm); oral solution of hyaluronic acid mixture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Injury and Osteoarthritis Outcome Score (KOOS)	A normalized score (0-100, 0 indicating extreme symptoms and 100 indicating no symptoms) was calculated.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	A normalized score (0-100, 0 indicating extreme symptoms and 100 indicating no symptoms) was calculated.	8 weeks
SF-36	each item was recorded into score with a 0 to 100 range. Higher scores mean a better outcome.	8 weeks
Chinese version Pittsburgh Sleep Quality Index (CPSQI)	Total score of CPSQI from 0 (better) to 21 (worse) was used as the indicators of sleep quality	8 weeks

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Collaborators: TOP Pharm & Medicalware
• Investigators: Principal Investigator: Shyu-Jye Wang, MD, China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: December 25, 2019
• First Submitted That Met QC Criteria: December 25, 2019
• First Posted (Actual): December 30, 2019

Study Record Updates

• Last Update Posted (Actual): January 3, 2020
• Last Update Submitted That Met QC Criteria: January 1, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: DMR101-IRB2-033

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No