A 12 Week, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial for the Evaluation of the Efficacy and Safety of Tabetri on Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- VAS (Visual Analogue Scale)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
tabetri
Tabetri capsule will be administered orally twice daily for 12 weeks
干预措施: Tabetri capsule (Dietary Supplement)
Placebo
Placebo capsule will be administered orally twice daily for 12 weeks
干预措施: Placebo capsule (Dietary Supplement)
结局指标
主要结局
VAS (Visual Analogue Scale)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- 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)