A Randomized, Double Blind, Single Simulation, Parallel Controlled, Multi-center Clinical Study of Guli Capsules in the Treatment of Knee Osteoarthritis
试验速览
- 阶段
- 4 期
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Osteoarthritis index on the Western Ontario and McMaster Universities Osteoarthritis Index
研究概览
简要总结
Previous study showed that Guli capsule could suppress the adjuvant multiple arthritis; have inhibitory effect on carrageenan gelatinous and formaldehyde foot swelling; improve the symptom of osteoporosis patients; and improve pain and limited joint activities of rheumatoid patients.
To further verify the clinical effect of Guli capsule in the treatment of knee osteoarthritis, the investigators perform this multi-center clinical study.
详细描述
Guli capsule, an approved Chinese patent drug, its main indications are for rheumatism, rheumatoid arthritis.
Previous study showed that Guli capsule could suppress the adjuvant multiple arthritis; have inhibitory effect on carrageenan gelatinous and formaldehyde foot swelling; improve the symptom of osteoporosis patients; and improve pain and limited joint activities of rheumatoid patients.
To further verify the clinical effect of Guli capsule in the treatment of knee osteoarthritis, the investigators perform this multi-center clinical study.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages between 40 and 70 years, both gender
- •Kellgren and Lawrence grades of I to III;
- •The subjects volunteered participate in the study and complied with the regulations and signed the written consent voluntarily.
- •Meet the following clinical and radiological criteria for diagnosis:
- •Clinical criteria:
- •most of the time have knee pain nearly a month
- •bone fricative
- •morning stiffness is less than or equal to 30 min
- •age is more than or equal to 38 years
- •bony enlargement. Who meet (1) + (2) or (1) + (4) + (5) can be diagnosed as knee osteoarthritis.
- •Radiological criteria:
- •most of the time have knee pain nearly a month
- •the X-ray showed osteophyte formation
- •joint fluid examination confirmed with osteoarthritis
- •age is more than or equal to 40 years
- •morning stiffness is less than or equal to 30 min
- •bone fricative. Meet (1) + (2) or (1) + (3) + (5) + (6) or (1) + (4) + (5) + (6).
排除标准
- •Patient with a history of allergy to similar constituents or chemical components of the drug;
- •Patients with limited liver and kidney function;
- •Patients with hematopoietic system disease;
- •Patients with diabetes, Cushing's syndrome and other endocrine disorders;
- •Patients with severe heart and brain disease;
- •Patients with low immunity;
- •Patients directly involved with the staff in the study;
- •Women during pregnancy or lactation;
- •Participating in other clinical studies or Participated in 3 months;
- •The investigators judged who be unfit for the study.
研究组 & 干预措施
Guli capsule
Guli capsule, the tested drug of this study
干预措施: Guli capsule (Drug)
Kangguzengsheng capsule
Kangguzengsheng capsule, a CFDA approved drug for articular genu osteoarthritis,is adopted as active comparator in this study
干预措施: Kangguzengsheng capsule (Drug)
结局指标
主要结局
Osteoarthritis index on the Western Ontario and McMaster Universities Osteoarthritis Index
时间窗: 4 weeks
次要结局
- Pain Scores on the Visual Analog Scale(4 weeks)
- Number of Participants with Adverse Events as a Measure of Safety(4 weeks)