A 12 Week, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial for the Evaluation of the Efficacy and Safety of Tabetri on Osteoarthritis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- Jaseng Medical Foundation
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- VAS (Visual Analogue Scale)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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).
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
VAS (Visual Analogue Scale)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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 Outcomes
- ESR (Erythrocyte sedimentation rate)(Change of the week 12 from baseline)
- Subject's global impression of change scale(6 and 12 weeks)
- Investigator's global impression of change scale(6 and 12 weeks)
- CRP (C-reactive protein)(Change of the week 12 from baseline)