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Effectiveness of Oral Hyaluronic Acid in Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
A+HA(tm)
Placebo
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female age >= 40 years old
  • Diagnosed with knee OA which met the definition of Ahlbӓck classification12 and had knee joint symptoms within 30 days prior to enrollment

Exclusion Criteria:

  • Had administered glucosamine one month prior to enrollment
  • Had known allergy to oral HA
  • BMI ≧40 kg/m2
  • Knee OA was caused by occupational hazard or sports injury
  • Patients with known other causes of arthritis (infectious rheumatoid or psoriatic arthritis), bony or soft tissue malignancy or peripheral neuropathy involving the lower extremities, cardiopulmonary disease which limited walking more than knee pain, knee instability defined as a report of knee buckling or locking within the past month of the study knee, major neurological deficit that affected gait, psychiatric illness that limited informed consent or Parkinsonism
  • Women in pregnancy
  • Wheel chair users

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 combination with glucosamine and chondroitin 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

WOMAC
Mean change from baseline to 8 weeks. The higher the score, the greater the severity.

Secondary Outcome Measures

SF-36
Mean change from baseline to 8 weeks. A higher score indicates a better QoL.

Full Information

First Posted
April 16, 2020
Last Updated
April 16, 2020
Sponsor
China Medical University Hospital
Collaborators
TOP Pharm & Medicalware
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1. Study Identification

Unique Protocol Identification Number
NCT04352322
Brief Title
Effectiveness of Oral Hyaluronic Acid in Knee Osteoarthritis
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
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 2012 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (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 study was a randomized, double-blind, placebo-controlled study evaluating the efficacy of an oral liquid HA supplement (A+HA) in symptoms relief and improvement of quality of life in knee osteoarthritis patients with mild knee pain.
Detailed Description
Subjects were initially screened at the Randomization/Baseline Visit (Week 0). Eligible subjects were randomized at the same visit into the treatment period and received the assigned treatment in a double-blind fashion for 8 weeks. During the 8 weeks treatment period, there were three follow-up visits requested (Week 2, Week 4 and Week 8). Efficacy was measured by using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Short Form-36 (SF-36).

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
ParticipantInvestigator
Allocation
Randomized
Enrollment
47 (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 combination with glucosamine and chondroitin 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 in combination with glucosamine and chondroitin
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
oral solution with no active ingredients
Primary Outcome Measure Information:
Title
WOMAC
Description
Mean change from baseline to 8 weeks. The higher the score, the greater the severity.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
SF-36
Description
Mean change from baseline to 8 weeks. A higher score indicates a better QoL.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female age >= 40 years old Diagnosed with knee OA which met the definition of Ahlbӓck classification12 and had knee joint symptoms within 30 days prior to enrollment Exclusion Criteria: Had administered glucosamine one month prior to enrollment Had known allergy to oral HA BMI ≧40 kg/m2 Knee OA was caused by occupational hazard or sports injury Patients with known other causes of arthritis (infectious rheumatoid or psoriatic arthritis), bony or soft tissue malignancy or peripheral neuropathy involving the lower extremities, cardiopulmonary disease which limited walking more than knee pain, knee instability defined as a report of knee buckling or locking within the past month of the study knee, major neurological deficit that affected gait, psychiatric illness that limited informed consent or Parkinsonism Women in pregnancy Wheel chair users
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

Plan to Share IPD
No
Citations:
PubMed Identifier
33592868
Citation
Wang SJ, Wang YH, Huang LC. The effect of oral low molecular weight liquid hyaluronic acid combination with glucosamine and chondroitin on knee osteoarthritis patients with mild knee pain: An 8-week randomized double-blind placebo-controlled trial. Medicine (Baltimore). 2021 Feb 5;100(5):e24252. doi: 10.1097/MD.0000000000024252.
Results Reference
derived

Learn more about this trial

Effectiveness of Oral Hyaluronic Acid in Knee Osteoarthritis

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