Randomized Study of Two Dosage Forms (Oral Powder and Capsule) of "Chondroitin + Glucosamine Sulfate" Produced by the Laboratory EMS When Compared to the Product Condroflex (Oral Powder and Capsules) Produced by Laboratory Zodiac in the Treatment of Osteoarthrosis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Decrease in pain.
研究概览
简要总结
This study objective is to check the non-inferiority of the 2 formulations produced by EMS when compared with the same substances and pharmaceuticals forms of the product Condroflex (Zodiac), by promoting the relief of osteoarthrosis symptoms such as pain, stiffness and functional capacity that will be periodically measured by using the "Visual Analog Scale" of pain (VAS) and the questionnaire of Lequesne.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who agree with all aspects of the study and sign the Informed Consent;
- •Patients of both sexes;
- •Age above 30 years;
- •Clinical and radiological diagnosis of osteoarthritis;
- •Osteoarthritis in grades 1-2;
- •Patients who are conducting medical treatment and that, for trial of Investigator, is eligible for the study.
排除标准
- •Patients with a history of trauma clinically significant;
- •Patients who underwent surgery on joints affected;
- •Coexistence of diseases that might impede the successful conclusion of the trial (rheumatism and others);
- •Pregnant patients and / or breastfeeding;
- •Patients with phenylketonuria;
- •Patients with clinical diagnosis of severe renal failure;
- •Patients with clinical diagnosis of severe liver disease;
- •Patients with clinical diagnosis of clotting disorders;
- •Patients who are being treated with anti-aggregating and / or anticoagulants;
- •Patients with sensitive components of the formula;
- •Patients with emotional disorders that interfere with the capture of data;
- •Patients who do not agree with the purposes of the study and did not sign the Informed Consent.
研究组 & 干预措施
Test 1
Oral Powder EMS
干预措施: EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder) (Dietary Supplement)
Test 2
Hard Capsules EMS
干预措施: EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules) (Dietary Supplement)
Comparator 1
Oral Powder Zodiac
干预措施: Zodiac: Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder) (Dietary Supplement)
Comparator 2
Hard capsules - Zodiac
干预措施: Zodiac Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules) (Dietary Supplement)
结局指标
主要结局
Decrease in pain.
时间窗: V0 (Screening); V1 (Inclusion); V2 (2 weeks); V3 (4 weeks); V4 (8 weeks); V5 (12 weeks); V6 (24 weeks).
次要结局
未报告次要终点