Therapeutic Effect of Combined Treatment of Oral Nutritional Supplement Based on Hyaluronic Acid With Hyaluronic Acid Intra-articular Injection on Symptomatic Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
研究概览
简要总结
The goal of this clinical trial is to investigate the effect of oral hyaluronate in patients with knee osteoarthritis. The main question it aims to answer is: the therapeutic effect in the combined treatment of oral nutritional supplement based on hyaluronic acid with hyaluronic acid intra-articular Injection on symptomatic knee osteoarthritis. Researchers will compare it to those who receive only hyaluronic acid injection to see if the combined treatment is better.
Participants will receive a total of three months of oral hyaluronate or placebo agents.
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)
盲法说明
both the patients and the investigators were blinded to the agent patients took
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiological evidence of osteoarthritis Ahlbäck stage I-III.
- •Had knee effusion at the suprapatellar recess under ultrasonographic examination.
- •Age between 60 and 75 years old.
排除标准
- •Rheumatological disorders
- •Accidental trauma or fractures involving knees in the past three months
- •Neuropathic pain involving lower limbs
- •Central nervous system disorders including stroke, Parkinsonism, and spinal cord disorders.
- •Depression and cognitive problems
研究组 & 干预措施
oral hyaluronate plus hyaluronate knee injection
oral hyaluronate plus hyaluronate knee injection
干预措施: oral hyaluronate and injection (Drug)
hyaluronate knee injection
hyaluronate knee injection
干预措施: hyaluronate injection (Drug)
结局指标
主要结局
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
时间窗: From enrollment to the end of treatment at 12 weeks
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) aim to reveal pain, stiffness and function of the knee, the minimum and maximum values are 0 and 68, and a higher score mean a worse outcome.
次要结局
- knee strength(From enrollment to the end of treatment at 12 weeks)
- Timed up and go test(From enrollment to the end of treatment at 12 weeks)