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

NCT04212741 | Completed

• 1 other identifier: DMR101-IRB2-033
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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).

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  8 weeks

• SF-36

  8 weeks

• Chinese version Pittsburgh Sleep Quality Index (CPSQI)

  8 weeks

Study Arms (2)

A+ HA(tm)

EXPERIMENTAL

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)

Placebo

PLACEBO COMPARATOR

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

Interventions

A+ HA(tm) DIETARY_SUPPLEMENT

oral solution of hyaluronic acid mixture

A+ HA(tm)

Placebo DIETARY_SUPPLEMENT

oral solution with no-active ingredients

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Use of Glucosamine within 1 month before enrollment
• Osteoarthritis of the knee due to exercise or occupational injury
• Allergy with Oral Hyaluronic Acid
• Bilateral Total Knee Replacement
• Pregnant
• Need use wheelchairs
• BMI≥40
• 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.
• Cancer

Sponsors & Collaborators

• China Medical University Hospital: lead
• TOP Pharm & Medicalware: collaborator

Study Sites (1)

TOP Pharm. & Medicalware

Taichung, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Shyu-Jye Wang, MD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2019
• First Posted: December 30, 2019
• Study Start: November 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 3, 2020

Record last verified: 2020-01

Locations

TW (1)