NCT03418155Unknown3 期
Efficacy and Safety of TongBi Capsule in Patients With Knee Osteoarthritis:a Randomized, Double-blind, Placebo-controlled Post - Market Clinical Study
Guang'anmen Hospital of China Academy of Chinese Medical Sciences1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The change from Baseline to week 4 in Visual Analog Scale (VAS)score
研究概览
简要总结
This study evaluates the efficacy and safety of TongBi capsule compared with placebo in the treatment of knee osteoarthritis in adults.Half of participants will receive TongBi capsule in combination,while the other half will receive a Placebo.
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, Investigator)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.45-75 years of age (including 45 years and 75 years old), men and women are not limited.
- •western medicine diagnosis of knee osteoarthritis, clinical classification for primary.
- •3.The severity of the imaging classification of K-L≤Ⅲ;
- •treatment VAS pain scores than 40mm (select the subjects most obvious limb pain symptoms).
- •informed consent form signed by the patient or legal representative.
排除标准
- •within 3 months prior to the trial, the patients were treated within intra-articular treatment.
- •4 weeks before the treatment, corticosteroids, non steroidal drugs, intra-articular injections or other drugs to improve the condition (such as cartilage protective agents) were used.
- •The screening period has any disease history or evidence:
- •The basic of serious cardiovascular and cerebrovascular diseases; An active, recurrent peptic ulcer or other hemorrhagic disease risk; Sales and other serious diseases of digestive system; An associated with malignant tumors, blood, or other serious diseases or system; Patients who are unable to cooperate or cooperate with other mental disorders.
- •Before the screening, any laboratory test indicators meet the following standards:
- •An admission of liver and kidney function showed that ALT and AST is more than 1.5 times the upper limit of the normal value, Cr is more than 1.2 times the upper limit of normal (Reference Research Center laboratory where the range of normal value); An other clinically significant laboratory abnormalities, and the researchers judged not into the group.
- •Allergic constitution or allergic to TongBi capsul, excipients or similar ingredients;
- •Professional athletes;
- •doubt or indeed history of alcohol and drug abuse;
- •participants who participated in other clinical trials within the first 3 months;
- •the researchers believe that patients should not participate in this clinical trial.
研究组 & 干预措施
Treatment of TongBi Capsule
Experimental
干预措施: Treatment of TongBi Capsule (Drug)
Treatment of TongBi Placebo
Placebo Comparator
干预措施: Treatment of TongBi placebo (Drug)
结局指标
主要结局
The change from Baseline to week 4 in Visual Analog Scale (VAS)score
时间窗: 0 weeks,2 weeks，4 weeks
VAS scores ranges from 0 to 100, with higher scores indicating heavier pain
次要结局
- The change from Baseline to week 4 in Western Ontarioand McMaster Universities(0 weeks,2 weeks and 4 weeks)
- The change from baseline to week 4 in The Short Form-36 Health Survey (SF-36) scores(0 weeks,4 weeks)
- The number of adverse events(4 weeks)
研究者
Quan Jiang
Director，Devision of Rheumatology
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
研究点 (1)
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