This clinical trial aims to clarify the effect of UltraHA® on knee joint conditions.
In this study, the investigators will evaluate the knee condition before and after the intervention. The groups to be compared are two different doses of UltraHA® and a placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
66
Take 2 capsules per day at any time.
Take 2 capsules per day at any time.
Take 2 capsules per day at any time.
Nerima Medical Association Minami-machi Clinic
Nerima-ku, Tokyo, Japan
Medical Corporation Seishinkai, Takara Clinic
Shinagawa-Ku, Tokyo, Japan
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at Week 12
The WOMAC contains 24 questions, including pain for 5 questions, stiffness for 2 questions, and physical function for 17 questions, answered on a range of 0 (mildest) to 4 (most severe). The sum of responses is evaluated as the WOMAC scores.
Time frame: Week 12
Each WOMAC subscale score at Week 12
The WOMAC contains 24 questions, including pain for 5 questions, stiffness for 2 questions, and physical function for 17 questions, answered on a range of 0 (mildest) to 4 (most severe). The sum of each subscale response is evaluated as the WOMAC subscale score.
Time frame: Week 12
Subjective symptoms at Week 12
Assess knee pain, stiffness, discomfort, and health using visual analogue scale. There is a 100 mm straight line with the best and worst degree of sensation indicated at both ends, and the current degree of sensation is marked on the line with the best imaginable state being 0 and the worst state being 100.
Time frame: Week 12
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