Efficacy and Safety of Tabetri on Osteoarthritis

Study Overview
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Brief Summary
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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
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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).

Official Title
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A 12 Week, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial for the Evaluation of the Efficacy and Safety of Tabetri on Osteoarthritis

Conditions
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Osteoarthritis

Intervention / Treatment
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* Dietary Supplement: Tabetri capsule
* Dietary Supplement: Placebo capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tabetri<br>Tabetri capsule will be administered orally twice daily for 12 weeks | Dietary Supplement: Tabetri capsule<br>* 1,000 mg/capsule (Taheebo extract 600 mg/day)<br>|
| Placebo Comparator: Placebo<br>Placebo capsule will be administered orally twice daily for 12 weeks | Dietary Supplement: Placebo capsule<br>* 1,000 mg/capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | Change of the week 6 and 12 from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | Change of the week 12 from baseline |