Back to resultsEffectiveness of Oral Hyaluronic Acid (A+ HA(tm), TOP Pharm.) in Knee Osteoarthritis: Clinical Trial
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
A+ HA(tm)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
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Sites / Locations
- TOP Pharm. & Medicalware
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A+ HA(tm)
Placebo
Arm Description
20 ml oral solution of hyaluronic acid mixture in a bottle. Administration with 250~500 ml water under fasting condition in the morning.
20 ml oral solution without active ingredients in a bottle. Administration with 250~500 ml water under fasting condition in the morning.
Outcomes
Primary Outcome Measures
Knee Injury and Osteoarthritis Outcome Score (KOOS)
A normalized score (0-100, 0 indicating extreme symptoms and 100 indicating no symptoms) was calculated.
Secondary Outcome Measures
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
A normalized score (0-100, 0 indicating extreme symptoms and 100 indicating no symptoms) was calculated.
SF-36
each item was recorded into score with a 0 to 100 range. Higher scores mean a better outcome.
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
Full Information
NCT ID
NCT04212741
First Posted
December 25, 2019
Last Updated
January 1, 2020
Sponsor
China Medical University Hospital
Collaborators
TOP Pharm & Medicalware
1. Study Identification
Unique Protocol Identification Number
NCT04212741
Brief Title
Effectiveness of Oral Hyaluronic Acid (A+ HA(tm), TOP Pharm.) in Knee Osteoarthritis: Clinical Trial
Official Title
Effectiveness of Oral Hyaluronic Acid (A+ HA(tm), TOP Pharm.) in Knee Osteoarthritis: Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital
Collaborators
TOP Pharm & Medicalware
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A+ HA(tm)
Arm Type
Experimental
Arm Description
20 ml oral solution of hyaluronic acid mixture in a bottle. Administration with 250~500 ml water under fasting condition in the morning.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
20 ml oral solution without active ingredients in a bottle. Administration with 250~500 ml water under fasting condition in the morning.
Intervention Type
Dietary Supplement
Intervention Name(s)
A+ HA(tm)
Intervention Description
oral solution of hyaluronic acid mixture
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
oral solution with no-active ingredients
Primary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
A normalized score (0-100, 0 indicating extreme symptoms and 100 indicating no symptoms) was calculated.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
A normalized score (0-100, 0 indicating extreme symptoms and 100 indicating no symptoms) was calculated.
Time Frame
8 weeks
Title
SF-36
Description
each item was recorded into score with a 0 to 100 range. Higher scores mean a better outcome.
Time Frame
8 weeks
Title
Chinese version Pittsburgh Sleep Quality Index (CPSQI)
Description
Total score of CPSQI from 0 (better) to 21 (worse) was used as the indicators of sleep quality
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shyu-Jye Wang, MD
Organizational Affiliation
China Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
TOP Pharm. & Medicalware
City
Taichung
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Oral Hyaluronic Acid (A+ HA(tm), TOP Pharm.) in Knee Osteoarthritis: Clinical Trial
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