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

NCT ID: NCT04212741

Last Updated: 2020-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

A+ HA(tm)

Intervention Type: DIETARY_SUPPLEMENT

oral solution of hyaluronic acid mixture

Placebo

20 ml oral solution without active ingredients in a bottle. Administration with 250\~500 ml water under fasting condition in the morning.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

oral solution with no-active ingredients

Interventions

A+ HA(tm)

oral solution of hyaluronic acid mixture

Intervention Type: DIETARY_SUPPLEMENT

Placebo

oral solution with no-active ingredients

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TOP Pharm & Medicalware

UNKNOWN

Sponsor Role: collaborator

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shyu-Jye Wang, MD

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

TOP Pharm. & Medicalware

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

DMR101-IRB2-033

Identifier Type: -

Identifier Source: org_study_id