Osteoarthritis
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DIETARY_SUPPLEMENTTabetri capsule
1,000 mg/capsule (Taheebo extract 600 mg/day)
DIETARY_SUPPLEMENTPlacebo capsule
1,000 mg/capsule
Sponsors
Nutribiotech Co., Ltd.
Neonutra
Jaseng Medical Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female 40 \ 75 years of age * VAS (Visual Analogue Scale) over 30mm * Kellgren & Lawrence Grade I\ II by X-ray * Subject who agrees to participate in this clinical trial by themselves and signs the Informed Consent Form (ICF)
Exclusion criteria
* Subjects who diagnosed inflammatory arthritis (rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, septic arthritis, gout) * Joint space under 2 mm by X-ray * Kellgren & Lawrence Grade over III with osteophyte, irregularly-shaped auricular surfaces, or subchondral bone cyst by X-ray * Subjects who diagnosed cardiovascular disease, immune disease, infectious diseases, tumor diseases * Subjects having gastrointestinal diseases * Uncontrolled hypertension patients (Blood pressure ≥ 160/100mmHg) * Uncontrolled diabetes mellitus patients (fasting glucose level ≥ 180mg/dl) * Patients with TSH \<= 0.1 uIU/mL or \>= 10 uIU/mL * Subjects have attended abnormal values at AST or ALT (3 times excess at upper limit of the normal values) * Subjects have attended abnormal values at creatinine (2 times excess at upper limit of the normal values) * Pregnancy, breast-feeding, or subjects who have a plan to pregnancy within 3 months * Use of osteoarthritis treatment drugs or dietary supplements within 2 weeks prior to screening * Psychiatric disorder patient (schizophrenia, depressive disorder, drug abuse) * History of osteoarthritis treatment therapy within 2 weeks prior to screening * Have participated in another clinical trial within the 3 months prior to screening * Subjects who have hypersensitivity history about investigational product * Have difficulty to be participated in this clinical trial by investigator's decision
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS (Visual Analogue Scale) | Change of the week 6 and 12 from baseline | 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. |
| K-WOMAC (Korean-Western Ontario and McMaster Universities) | Change of the week 6 and 12 from baseline | 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). |
| KSF-36 (Korean-Short Form Health Survey 36) | Change of the week 6 and 12 from baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject's global impression of change scale | 6 and 12 weeks | 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 |
| CRP (C-reactive protein) | Change of the week 12 from baseline | CRP to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline |
| Investigator's global impression of change scale | 6 and 12 weeks | 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 |
| ESR (Erythrocyte sedimentation rate) | Change of the week 12 from baseline | ESR to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline |
Countries
South Korea
Outcome results
None listed