Unique ID issued by UMIN | UMIN000042608 |
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Receipt number | R000048628 |
Scientific Title | Comparison of efficacy of two high-molecular-weight hyaluronic acid products in patients with knee osteoarthritis. Randomized, double-blind, clinical trial comparing hyaluronic acid products of average molecular weights of 900,000 and 1.9 million. |
Date of disclosure of the study information | 2020/12/01 |
Last modified on | 2020/12/01 12:21:57 |
Comparison of efficacy of two high-molecular-weight hyaluronic acid products in patients with knee osteoarthritis
Comparative study of hyaluronic acid products in patients with knee osteoarthritis
Comparison of efficacy of two high-molecular-weight hyaluronic acid products in patients with knee osteoarthritis.
Randomized, double-blind, clinical trial comparing hyaluronic acid products of average molecular weights of 900,000 and 1.9 million.
A randomized, double-blind, clinical trial comparing high-molecular-weight hyaluronic acid products in patients with knee osteoarthritis.
Japan |
knee osteoarthritis
Orthopedics |
Others
NO
Improvement of knee joint pain and improvement of quality of life
Comparison of efficacy of two high-molecular-weight hyaluronic acid products
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Japanese Knee Osteoarthritis Measure and Pain visual analog scale
Side effects and complications
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Pseudo-randomization
2
Treatment
Medicine |
High molecular weight hyaluronic acid preparation with an average molecular weight of 900,000. The dosing interval is once a week for 5 weeks, up to 5 times.
From 6 weeks to 24 weeks, the dosing interval is about twice a month.
High molecular weight hyaluronic acid preparation with an average molecular weight of 1.9 million. The dosing interval is once a week for 5 weeks, up to 5 times.
From 6 weeks to 24 weeks, the dosing interval is about twice a month.
40 | years-old | <= |
Not applicable |
Male and Female
Knee osteoarthritis
Knee pain
Kellgren - Lawrence Classification from grade 1 to grade 3
Cases where the treatment policy has changed due to the improvement or worsening of symptoms or the appearance of side effects.
Cases where you cannot answer the questionnaire yourself.
Cases where it is difficult to visit the hospital 5 times in a row.
60
1st name | Hiroyuki |
Middle name | |
Last name | Onuma |
Kawasaki Municipal Tama hospital
Orthopaedic surgery
214-8525
1-30-37, Shukugawara, Tama-ku, Kawasaki city
+81-(0)44-933-8111
herrhiro@marianna-u.ac.jp
1st name | Hiroyuki |
Middle name | |
Last name | Onuma |
Kawasaki Municipal Tama hospital
Orthopaedic surgery
214-8525
1-30-37, Shukugawara, Tama-ku, Kawasaki city
+81-(0)44-933-8111
herrhiro@marianna-u.ac.jp
International University of Health and Welfare
None
Other
None
None
None
International University of Health and Welfare Hospital Ethics Review Committee
537-3 Iguchi, Nasushiobara City, Tochigi Prefecture
0287-37-2221
atakaku@iuhw.ac.jp
NO
国際医療福祉大学病院/International University of Health and Welfare Hospital
2020 | Year | 12 | Month | 01 | Day |
N/A
Unpublished
N/A
54
54 people in total, 16 men, 38 women, 900,000 groups, 27 people, 1.9 million groups, 27 people, 2 deviations, 3 withdrawal of consent
Both HA products alleviated walking pain and JKOM scores and their symptoms continued to improve with continued injections for 6 months.
2020 | Year | 12 | Month | 01 | Day |
None
2013 | Year | 04 | Month | 30 | Day |
Orthopedic outpatient with knee osteoarthritis
Participate if consent is obtained, explanation of treatment contents and research, explanation of how to proceed with research.
Swelling, redness, exacerbation of pain, systemic symptoms
Japanese Knee Osteoarthritis Measure, visual anologue scale of pain
None
None
Completed
2009 | Year | 08 | Month | 25 | Day |
2009 | Year | 08 | Month | 25 | Day |
2009 | Year | 11 | Month | 30 | Day |
2013 | Year | 04 | Month | 30 | Day |
2013 | Year | 08 | Month | 31 | Day |
2013 | Year | 08 | Month | 31 | Day |
2013 | Year | 08 | Month | 31 | Day |
Esumi Co., Ltd.
Analysis consultant department
statistician
Takashi Fukushima
2020 | Year | 12 | Month | 01 | Day |
2020 | Year | 12 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048628
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