NCT03327012Unknown3 期
Efficacy and Safety of Panlongqi Tablet in Patients With Knee Osteoarthritis:A Multicenter, Randomized, Double-blind, Placebo-controlled Parallel 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 300 人开始时间: 2017年11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
- 300
- 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 Panlongqi tablet compared with placebo in the treatment of knee osteoarthritis in adults.Half of participants will receive Panlongqi tablet in combination,while the other half will receive a Placebo.
详细描述
The test group will be given Panlongqi tablet 1.2g three times per day,the control group will be given placebo 1.2g three times per day. The invention will last 4 weeks.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.40-75 years of age (including 40 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 1 years.
- •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.
- •Swelling of the knee joint.
- •knee synovial crystalline (joint) inflammation, acute inflammatory arthritis, rheumatoid arthritis, metabolic bone disease, psoriatic arthritis, septic arthritis, systemic lupus erythematosus, Sjogren syndrome, vasculitis and other rheumatic diseases caused by inflammatory arthritis and endocrine diseases caused by.
- •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 test seven tablets, excipients or similar ingredients;
- •doubt or indeed history of alcohol and drug abuse;
- •pregnant or lactating women or recent planned pregnancies and those who are reluctant to use contraceptives;
- •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 Panlongqi Tablet
Experimental
Patients were treated with Panlongqi Tablet.
干预措施: Treatment of Panlongqi Tablet (Drug)
Treatment of Panlongqi Placebo
Placebo Comparator
Patients were treated with Panlongqi Placebo Tablet.
干预措施: Treatment of Panlongqi 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 number of adverse events(4 weeks)
- The change from Baseline to week 4 in Western Ontarioand McMaster Universities Osteoarthritis Index (WOMAC)score(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)
研究者
Quan Jiang
Director，Devision of Rheumatology
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
研究点 (1)
Loading locations...
相似试验
Unknown
3 期
Efficacy and Safety of TongBi Capsule in Patients With Knee OsteoarthritisKnee OsteoarthritisNCT03418155Guang'anmen Hospital of China Academy of Chinese Medical Sciences200
Unknown
2 期
Phase Ⅱc Sutdy of Aolanti Weikang Tablets in FD PDS PatientsFunctional DyspepsiaNCT03971383Jiangxi Qingfeng Pharmaceutical Co. Ltd.236
Unknown
4 期
Efficacy and Safety Study of Guanxin Shutong Capsule to Treat Chronic Stable AnginaAngina, StableNCT02280850Shaanxi Buchang Pharmaceutical Co., Ltd300
Unknown
4 期
Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney DiseaseChronic Kidney DiseaseNCT02885857Chen Xiangmei1,500
招募中
4 期
Effect of Yangxinshi Tablet on Exercise Tolerance in Patients With Chronic Coronary Syndrome（MET STUDY）Chronic Coronary SyndromeNCT05978089Dongzhimen Hospital, Beijing120