CTRI/2019/05/019179尚未招募2/3 期
Evaluation of the efficacy and safety of PR/HC/1718/001 in knee osteoarthritis: A randomized double-blind controlled clinical study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assessment in Improvement in SF-36 Health Survey score
研究概览
简要总结
· This study is a randomized double blind parallel group placebo controlled study, this study is aimed to check efficacy and tolerability of PR/HC/1718/001 in knee osteoarthritis patients of either sexes as an adjuvant treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex, 40 to 70 years of age.
- •Diagnosis of OA knees , based on typical history, clinical presentation, classical radiological findings and fulfilling the ACR classification criteria for OA knees 3 Presence of typical osteophytes on skiagram knee is mandatory
- •A minimum pain VAS score > 4 on walking in one or both knees during the 24 hours preceding recruitment.
- •Patient with or without receiving regular anti – inflammatory or analgesic drugs, or are not satisfied with drugs being taken and seek a change.
- •Willing to come for regular follow – up visits.
- •Written Informed Consent from the patient.
排除标准
- •1.Patients with congenital arthropathy, rheumatoid arthritis, active gout, other type of arthritis with/without inflammation e.g. septic , fibromyalgia or collagen vascular disease 2.Patients with known history of coagulopathies 3.Osteoarthritis of any other joint except knee 4.Patients with history of major trauma or surgery in the knee joint 5.Patients with uncontrolled diabetes and hypertension
- •Body mass index (BMI) >40 kg/m
- •7.Patients with any severe cardiac, renal and hepatic disease 8.Pregnant and lactating women 9.Patients who participated in any clinical trial within 30 days before enrollment into the study.
结局指标
主要结局
Assessment in Improvement in SF-36 Health Survey score
时间窗: Baseline to day 30, Day 60 and Day 90
Assessment of performance of patient on pain VAS scale.
时间窗: Baseline to day 30, Day 60 and Day 90
Assessment of WOMAC
时间窗: Baseline to day 30, Day 60 and Day 90
Assessment of patients Global Assessment, Physicians global Assessment
时间窗: Baseline to day 30, Day 60 and Day 90
Local examination, clinical signs
时间窗: Baseline to day 30, Day 60 and Day 90
次要结局
- Assessment of tolerability of study drug by assessing adverse events, serious adverse events during the study period.(Assessment of vitals during the study period)
研究者
研究点 (1)
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