This study is a 12-week, multicenter, randomized, double-blind, placebo-controlled clinical trial in order to evaluate the efficacy and safety of tabetri on osteoarthritis.
This study is prospectively conducted to investigate the efficacy and safety of tabetri in patients diagnosed with osteoarthritis at 4 locations of Jaseng Hospital of Korean Medicine (Gangnam, Haeundae, Daejeon, and Bucheon).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
100
1,000 mg/capsule (Taheebo extract 600 mg/day)
1,000 mg/capsule
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, Gyeonggi-do, South Korea
Haeundae Jaseng Hospital of Korean Medicine
Busan, South Korea
Daejeon Jaseng Hospital of Korean Medicine
Daejeon, South Korea
Jaseng Hospital of Korean Medicine
Seoul, South Korea
VAS (Visual Analogue Scale)
VAS is used to measure changes in joint pain on 6 and 12 weeks after administration in comparison with baseline. It is presented as a 100-mm horizontal line on which the patient's pain intensity is presented by a point between the extremes of "no pain at all" and "worst pain imaginable."
Time frame: Change of the week 6 and 12 from baseline
K-WOMAC (Korean-Western Ontario and McMaster Universities)
K-WOMAC is used to measure changes in joint pain and function on 0, 6, and 12 weeks after administration in comparison with baseline. It measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).
Time frame: Change of the week 6 and 12 from baseline
KSF-36 (Korean-Short Form Health Survey 36)
KSF-36 is used to measure changes in physical and mental function on 0, 6, and 12 weeks after administration in comparison with baseline. It is a 36-item self-report measure designed to assess health-related functioning. It contains eight subscales with four pertaining to physical functioning and four pertaining to psychological functioning. Scores on each subscale can range from 0 to 100, with a higher score representing better health-related functioning. Two composite scores are calculated by averaging all of the scores for four subscales pertaining to each of the two general aspects of functioning.
Time frame: Change of the week 6 and 12 from baseline
Subject's global impression of change scale
The change in activity limitations, symptoms, emotions and overall quality of life, related to painful condition that is assessed by subject Level of Quality * Excellent (category 1): substantial overall improvement of symptoms * Good (category 2): overall improvement of symptoms * Neutral (category 3): no change compared with before * Worse (category 4): overall deterioration of symptoms * Very much worse (category 5): substantial overall deterioration of symptoms
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 6 and 12 weeks
Investigator's global impression of change scale
The change in activity limitations, symptoms, emotions and overall quality of life, related to painful condition that is assessed by investigator Level of Quality * Excellent (category 1): substantial overall improvement of symptoms * Good (category 2): overall improvement of symptoms * Neutral (category 3): no change compared with before * Worse (category 4): overall deterioration of symptoms * Very much worse (category 5): substantial overall deterioration of symptoms
Time frame: 6 and 12 weeks
ESR (Erythrocyte sedimentation rate)
ESR to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline
Time frame: Change of the week 12 from baseline
CRP (C-reactive protein)
CRP to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline
Time frame: Change of the week 12 from baseline