Efficacy and Safety of Prednisolone and Chloroquine Add on Therapy in Osteoarthritis of the Knee Treated With Fixed Dose Combination of Glucosamine and Chondroitin Sulfate.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA)
研究概览
简要总结
This study was conducted to evaluate the efficacy and safety of prednisolone and chloroquine add on therapies to combined glucosamine, chondroitin sulfate in osteoarthritis of the knee which will be done in contrast to combined glucosamine sulfate and chondroitin.
详细描述
Fixed dose glucosamine, chondroitin sulfate combination is a treatment to osteoarthritis with some controversy about efficacy. it seems that addition of other agents may improve efficacy and decrease the required dose and cost. common oral corticosteroids such as low dose prednisolone and chloroquine are candidate for such add on therapies. nevertheless, add on therapy may expose the patients to new side effects which should followed and addressed.
In this investigator blinded controlled trial, 240 patients with diagnosed osteoarthritis of knee will be enrolled to the study. the patients will randomly be assigned to one of four groups of G (glucosamine and chondroitin sulfate ), P (Glucosamine and Chondroitin sulfate plus Prednisolone), C (Glucosamine and Chondroitin sulfate plus Chloroquine) and PC (Glucosamine and Chondroitin sulfate plus Prednisolone and Chloroquine). each group will consist 60 patients. the investigator(s) will be blind to the groups and interventions.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and non-pregnant women, age 40-85 years with primary OA of at least one knee.
排除标准
- •secondary arthritis related to systemic inflammatory arthritis (including rheumatoid arthritis, psoriatic arthritis, post-infectious arthritis and metabolic arthritis, traumatic arthritis or surgical joint replacement)corticosteroid use:
- •oral corticosteroid within the previous 14 days
- •intramuscular corticosteroid within 30 days
- •intraarticular corticosteroid into the study knee within 90 days
- •intra-articular corticosteroid into any other joint within 30 days or
- •topical corticosteroid at the site of application within 14 days
- •ongoing use of prohibited medication including NSAID, other oral analgesic, muscle relaxant, or low-dose antidepressant for any chronic pain management
- •glucosamine or chondroitin within the previous six months
- •history of alcohol or drug abuse
- •lactation
- •concomitant skin disease at the application site
- •current application for disability benefits on the basis of knee osteoarthritis; fibromyalgia; other painful or disabling condition affecting the knee
研究组 & 干预措施
Glucosamine and chondroitin sulfate
in this group patients will receive Glucosamine and chondroitin sulfate oral dietary supplementation
干预措施: Glucosamine and chondroitin sulfate (Drug)
P :glucosa, chondroitin, Prednis
in this group patients will receive glucosamine and chondroitin sulfate plus Prednisolone oral administration
干预措施: glucosamine and chondroitin sulfate plus Prednisolone (Drug)
Glucosa, Chondroitin, Chloroquine
in this group pateints will orally receive Glucosamine and Chondroitin sulfate plus Chloroquine.
干预措施: Glucosamine and Chondroitin sulfate plus Chloroquine (Drug)
Glucosa, Chondro, Prednis,Chloroq
in this group patients will receive Glucosamine and Chondroitin sulfate plus Prednisolone and Chloroquine
干预措施: Glucosamine,Chondroitin sulfate,Prednisolone,Chloroquine (Drug)
结局指标
主要结局
The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA)
时间窗: the outcome is assessed at 12 weeks after baseline visit
次要结局
- The secondary measure will be changes in stiffness(the outcome is assessed at 12 weeks after baseline visit)