The Assessment of TCI633 Probiotics on Pain Relief and Functional Improvement in Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- WOMAC™ Osteoarthritis Index
研究概览
简要总结
To assess TCI633 probiotics on pain relief and functional improvement in osteoarthritis
详细描述
This is a double-blind and randomized study. Subjects are informed to consume the samples before meals in the morning every day. The clinical and radiological diagnosis of osteoarthritis of the knee is evaluated by the doctor. The blood samples and questionnaires are collected at every visit of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Dietary Supplement)
TCI633
Testing product
干预措施: TCI633 (Dietary Supplement)
Type 2 collagen
Known drug for OA
干预措施: Type 2 collagen (Drug)
结局指标
主要结局
WOMAC™ Osteoarthritis Index
时间窗: Change from baseline at 6 months
The questionnaire includes three-part: i) join pain (five questions); ii) joint stiffness (two questions); and, iii) physical functions of joints (seventeen questions). Each question is scored 0-4. Low to high WOMAC scores represent slight to severe OA symptoms. The lower scores mean a better outcome.
KL Grade (evaluated by doctor)
时间窗: Change from baseline at 6 months
Pain relief and functional improvement in osteoarthritis
次要结局
- Blood C-reactive protein (CRP) level(Change from baseline at 6 months)
- Blood C-terminal telopeptide of collagen type II (CTX-II) level(Change from baseline at 6 months)