CTRI/2025/11/097728尚未招募4 期
Intra articular triamcinolone vs oral methotrexate in knee osteoarthritis:an open labelled randomized control trial
IPGMER AND SSKM1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2025年12月1日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- A) Improvement in WOMAC pain subscale score (0-100) at 12 weeks and ICOAP score
研究概览
简要总结
This is an open labeled RCT to compare between the efficacy of methotrexate and IACS in osteoarthritis .OA is a both degenerative and inflammatory.As it is difficult to control pain and inflammation in OA,we are performing this RCT to analyze the response to treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •a Age 40 to 75 years b Satisfying ACR criteria for classification and reporting of osteoarthritis of knee joint 1986 c Symptomatic for at least 6 months d Radiographic Kellgren Lawrence grade II definite osteophyte and unimpaired joint space or grade III moderate multiple osteophytes definite narrowing of joint space some sclerosis and possible deformity of bone contour e Visual analog score for knee pain at least 40 or more on the scale of 0 to 100 f Failure to control osteoarthritis symptoms with conventional therapy defined as persistence of pain of severity 40 or more on VAS scale of 0 to 100 despite conventional treatment defined as one of the following medications taken daily during the preceding 3 month acetaminophen 2 to 4 gram per day maximum tolerated and recommended dose of an NSAID or acetaminophen codeine combination g Evidence of inflammation any two of the following presence of effusion in the knee joint as detected from bulge sign or patellar tap evidence of synovial inflammation on MRI knee joints or raised CRP h BMI less than 30 kg per meter square.
排除标准
- •b Seropositivity for RF anti CCP or ANA c History of trauma in the knees sufficient to reduce the mobility of the patient for at least 7 days in the past 1 year d Taking any other therapy for osteoarthritis except topical or systemic NSAIDS including any conventional DMARD e History of intraarticular glucocorticoid in knee joint in last 3 months f History of oral inhaled or intranasal glucocorticoid within one month g History of intraarticular hyaluronic acid in the knee within six months h Arthroscopic or open surgery of knee i History of knee replacement j Known hypersensitivity to corticosteroid k Patients with chronic inflammatory rheumatic disease Rheumatoid arthritis spondyloarthropathy psoriatic arthritis gout chondrocalcinosis or other autoimmune disease l Serum creatinine more than 15 mg per dL and deranged LFT m Patients with any history suggestive of multiple sclerosis or CNS demyelinating disease n Persons with uncontrolled diabetes mellitus unstable ischemic heart disease congestive heart failure active inflammatory bowel disease recent stroke chronic leg ulcer active hepatitis B and C infection positive HIV status history of infection requiring treatment with IV antibiotics in last 6 months o History of tuberculosis in last 2 years p Unwilling to give consent and unwilling to follow up.
结局指标
主要结局
A) Improvement in WOMAC pain subscale score (0-100) at 12 weeks and ICOAP score
时间窗: A) Improvement in WOMAC pain subscale score (0-100) at 12 weeks and ICOAP score | B) To compare between oral methotrexate and IACS in terms of efficacy of pain relief.
B) To compare between oral methotrexate and IACS in terms of efficacy of pain relief.
时间窗: A) Improvement in WOMAC pain subscale score (0-100) at 12 weeks and ICOAP score | B) To compare between oral methotrexate and IACS in terms of efficacy of pain relief.
次要结局
未报告次要终点
研究者
Sashwat Swayang SiddhaTarenia
IPGMER AND SSKM
研究点 (1)
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