A Multi-center, Randomized, Double Blind, Comparative of Efficacy and Safety From Association of Capsules Glucosamine and Chondroitin Sulfate (Eurofarma) Versus Cosamin DS to Treatment With Osteoarthrosis of the Knee
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- To Assess the Efficacy and Safety of the Association of Glucosamine Sulphate 500 mg/Chondroitin Sulphate 400 mg (Eurofarma) in the Treatment of Osteoarthritis, Compared to Cosamin DS® (Nutramax)in Same Presentation and Pharmaceutical Form
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of glucosamine and chondroitin sulfate association in the treatment of patients with osteoarthrosis of the knee.
详细描述
To assess the efficacy and safety of the association of glucosamine sulphate 500 mg/chondroitin sulphate 400 mg (Eurofarma) in the treatment of osteoarthritis, compared to Cosamin DS® (Nutramax) in same presentation and pharmaceutical form.
Some eligibility criteria:
Osteoarthritis of the knee confirmed by radiological examination; Visual analogue scale (VAS) > 40 mm; Clinical diagnosis of pain and functional limitation
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects have to read and sign the approved the Informed Consent form prior to any participation in the study.
- •Male or female Subjects, aged upper to 40 years.
- •Osteoarthritis of the knee confirmed by radiological examination.
- •Visual analogue scale (VAS) > 40 mm.
- •Kellgren and Lawrence grade 1 to
- •Clinical diagnosis of pain and functional limitation.
排除标准
- •History of significant trauma or surgery in the affected joint.
- •Pregnant women, lactating or not using appropriate contraceptive method.
- •History or presence of active rheumatic disease that may be responsible for secondary osteoarthritis.
- •Severe inflammation of the joint confirmed by physical examination (excluding also erythrocyte sedimentation <40mm/h and rheumatoid factor <1:40).
- •Body mass index >
- •Hematologic abnormalities, liver, renal or metabolic functions which undermine the serious participation of the patient (at investigator's criteria).
- •Systemic administration and/or intra-articular corticosteroids in the last 3 months.
- •Have made use of glucosamine and/or chondroitin.
- •Lequesne index of >
- •Arthroplasty in the affected joint.
- •Use of narcotic analgesics.
- •Any condition that, in the opinion of the investigator, renders the patient unable to participate in the study.
研究组 & 干预措施
Cosamin DS®
glucosamine hydrochloride 500 mg and chondroitin sulfate 400 mg (Cosamin DS®, Nutramax Laboratories).
The medication was supplied as capsules, with the daily dose of 3 capsules.
干预措施: Cosamin DS® (Nutramax) (Drug)
Glucosamine/ chondroitin sulphate
Glucosamine hydrochloride 500 mg and chondroitin sulphate 400 mg association (Eurofarma) T.I.D. before each meal The medication was supplied as capsules, with the daily dose of 3 capsules.
干预措施: Glucosamine sulphate and chondroitin sulphate association (Drug)
结局指标
主要结局
To Assess the Efficacy and Safety of the Association of Glucosamine Sulphate 500 mg/Chondroitin Sulphate 400 mg (Eurofarma) in the Treatment of Osteoarthritis, Compared to Cosamin DS® (Nutramax)in Same Presentation and Pharmaceutical Form
时间窗: approximately 5 months
To assess the efficacy and safety of the association of glucosamine sulphate 500 mg/chondroitin sulphate 400 mg (Eurofarma) in the treatment of osteoarthritis, compared to Cosamin DS® (Nutramax) in same presentation and pharmaceutical form.
次要结局
未报告次要终点