NCT05398874已完成不适用
Clinical Efficacy of Ginkgo Biloba Extract in the Treatment of Knee Osteoarthritis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- KOOS score
研究概览
简要总结
To assess the efficacy and safety of the Ginkgo biloba extract in patients with Knee OA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- 否
入选标准
- •patients 40-75 years old with knee OA.
- •Grade II and Grade III according to the Kellgrenn-Lawrence (KL) grading system of radiographic OA.
排除标准
- •Pregnancy, breastfeeding
- •Liver or renal problems
- •Patient taking any drug that might interact with Ginkgo extract (eg. warfarin, etc.)
- •patient with cardiovascular or cerebral vascular disorders, uncontrolled diabetes, allergic to ginkgo, recent surgery or hospital admission, >75 years old.
- •Allergic or contraindicated to using NSAIDs
研究组 & 干预措施
Ginkgo + standard
Active Comparator
the patients received Ginkgo biloba extract in addition to standard treatment
干预措施: Ginkgo biloba extract + standard treatment( paracetamol+Diclofenac100mg SR) (Combination Product)
placebo + standard
Placebo Comparator
the patients received a placebo in addition to the standard treatment
干预措施: placebo in addition to the standard treatment (Combination Product)
结局指标
主要结局
KOOS score
时间窗: Changes occured : baseline , 2 weeks , 4 weeks ,and 8 weeks
42 item questionnaire to assess pain, other symptoms, activities of daily living (ADL), sport and recreation function (Sport/Rec) and knee-related quality of life (QOL).
次要结局
- IL-6(Changes occured: baseline , 4 weeks,and 8 weeks)
- TNF-alpha(Changes occured: baseline , 4 weeks,and 8 weeks)
- urinary CTX-II(Changes occured :baseline , 4 weeks,and 8 weeks)
研究者
研究点 (1)
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