Randomized Evaluation Of Not Less Medical Association Chondroitin Sulfate Plus Glucosamine Sulfate (In Powder Dosage Forms And Oral Capsule), Manufactured By The Geolab Pharmaceutical Industry Ltd, Compared To The Drug Condroflex® (Powder And Oral Capsule), Manufactured In The Laboratory Zodiac, The Treatment Of Osteoarthritis.
试验速览
- 阶段
- 3 期
- 入组人数
- 320
- 主要终点
- Promotion of pain relief in patients with osteoarthritis.
研究概览
简要总结
The use of chondroitin sulfate and glucosamine sulfate has been recognized since the 70 decade in the treatment of osteoarthritis. Numerous clinical trials have demonstrated the therapeutic properties of this association in control of osteoarthritis, especially in reducing pain and improving movement. The combination of chondroitin sulfate with glucosamine sulfate offers a significantly higher tolerance than most drug treatments and, moreover, has long lasting effects even after stopping treatment.
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
- Single (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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Chondroitin Sulfate + Glucosamine sulfate
Pharmaceutical form capsule.
干预措施: Chondroitin sulfate + Glucosamine sulfate (Drug)
Chondroitin Sulfate + Glucosamine Sulfate
Oral powder.
干预措施: Chondroitin sulfate + Glucosamine sulfate (Drug)
Condroflex®
Pharmaceutical form capsule.
干预措施: Chondroitin sulfate + Glucosamine sulfate (Drug)
CONDROFLEX®
Oral powder
干预措施: Chondroitin sulfate + Glucosamine sulfate (Drug)
结局指标
主要结局
Promotion of pain relief in patients with osteoarthritis.
时间窗: 4 months.
Assessment of noninferiority clinical association Chondroitin + glucosamine in dosage forms and oral powder hard gelatin capsule, produced by Geolab Pharmaceutical Ltd., with the comparator drugs in the same dosage forms produced by the Laboratory Zodiac (Condroflex ®) through the promotion of pain relief in patients with osteoarthritis between grades 1 and 3, according to the classification of Kellgreen \& Lawrence (1957), measured by visual analogue scale (VAS). There will be five visits: V0, V1, V2, V3 and V4.
次要结局
- Functional capacity, overall assessment of clinical improvement, assessment of adverse events(4 months.)