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

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: NCT04212741
• Other study ID #: DMR101-IRB2-033
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: July 2014

Study information

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

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Dietary Supplement:
• A+ HA(tm)
oral solution of hyaluronic acid mixture
• 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	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	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
Secondary	SF-36	each item was recorded into score with a 0 to 100 range. Higher scores mean a better outcome.	8 weeks
Secondary	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