Effects Of Native Collagen Type 2 Treatment In Knee Osteoarthritis : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 主要终点
- the Change From Baseline in Pain During Walking Visual Analog Scale (VAS Walking)
研究概览
简要总结
The aim of this study was to evaluate symptomatic efficacy of native collagen type 2 on joint pain and function and its effects on urinary biological markers related to cartilage degeneration in patients with knee osteoarthritis.
详细描述
39 patients diagnosed with knee osteoarthritis were separated into two groups. The 1st group includes 19 patients given 1500mg/day paracetamol, the 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months.Pretreatment and posttreatment Visual Analog Scale, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), 20-m walking time and Short Form-36 (SF-36), Coll2-1, Coll2-1NO2 and Fibulin-3 levels in urine were compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 45-70 years with the diagnosis of primary knee OA according to the American College of Rheumatology (ACR) criteria, Kellgren Lawrence radiological stage II or III and knee pain -
排除标准
- •Patients with intraarticular injections or physical therapy within the last year, a previous lower extremity surgery, oral treatment with glucosamine chondroitin or other natural health products within the last month, serious concomitant systemic diseases, peripheral or central neurological disorder, hypersensitivity to paracetamol or se¬vere cardiac, renal, hepatic, hematologic disease
研究组 & 干预措施
paracetamol
The 1st group includes 19 patients given 1500mg/day paracetamol for three months
干预措施: paracetamol (Drug)
native collagen type 2 + paracetamol
The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months
干预措施: paracetamol+native collagen type 2 (Drug)
结局指标
主要结局
the Change From Baseline in Pain During Walking Visual Analog Scale (VAS Walking)
时间窗: 3 months
Post treatment comparison of VAS walking between the groups minimum score is 0, maximum score is 10. The clinic of the patient worses when the score increases.
次要结局
- the Change From Baseline in Coll2-1 Levels(3 months)
- the Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score(3 months)
- the Change From Baseline in 20 Meters Walking Time(3 months)
- the Change From Baseline in Short Form 36 / Bodily Pain Subgroup(3 months)
研究者
Onur Armağan
Onur Armagan, Medical Doctor
Eskisehir Osmangazi University