The purpose of this study is to evaluate efficacy and safety of Imotun capsule in osteoarthritis of the knee
This is a six-month, multicenter, randomized, double blind, parallel-group,placebo controlled study. Patients take Imotun capsules or placebo once a day, between the meals. Patients are allowed to take study drugs during the meal in the case of intolerant reflux of oil smell from GI. If patients do not tolerate the pain, they are able to take Celecoxib as a rescue medication during 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
234
Imotun capsule: Avocado-Soya Unsaponifiables 300.03mg/Cap, per oral, a capsule once a day during for 24 weeks
Imotun capsule placebo: per oral, a capsule a day during 24 weeks
Chungbuk National University Hospital
Cheongju-si, Chungcheonbuk-do, South Korea
Inje University Busan Paik Hospital
Busan, South Korea
Kyungpook National University Hospital
Daegu, South Korea
100mm pain VAS
assessment of the 100mm pain VAS
Time frame: 24 weeks
change from baseline Lequesne's index score at 24 weeks
Time frame: baseline, 24 weeks
change from baseline Lequesne's index score at 4 weeks
Time frame: baseline, 4 weeks
change from baseline 100mm pain VAS at 4 weeks
Time frame: baseline, 4 weeks
100mm pain VAS
assessment of 100mm pain VAS
Time frame: 4 weeks
global assessment
global assessment by physician and patient
Time frame: 4 weeks
administration days of the rescue medication
Time frame: 24 weeks
The rate of patients who consumed the rescue medication
Time frame: 24 weeks
change from baseline Lequesne's index score at 8 weeks
Time frame: baseline, 8 weeks
change from baseline Lequesne's index score at 16 weeks
Time frame: baseline, 16 weeks
change from baseline 100mm pain VAS at 8 weeks
Time frame: baseline, 8 weeks
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Chonnam National University Hwasun hospital
Hwasun, South Korea
Chonbuk National University Hospital
Jeonju, South Korea
Bundang CHA medical center
Seongnam, South Korea
Seoul National University Hospital
Seoul, South Korea
KyungHee University Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
ASAN Medical Center
Seoul, South Korea
change from baseline 100mm pain VAS at 16 weeks
Time frame: baseline, 16 weeks
change from baseline 100mm pain VAS at 24 weeks
Time frame: baseline, 24 weeks
100mm pain VAS
assessment of 100mm pain VAS
Time frame: 8 weeks
100mm pain VAS
assessment of 100mm pain VAS
Time frame: 16 weeks
global assessment
global assessment by physician and patient
Time frame: 8 weeks
global assessment
global assessment by physician and patient
Time frame: 16 weeks
global assessment
global assessment by physician and patient
Time frame: 24 weeks
dosing quantity of the rescue medication
Time frame: 24 weeks