CTRI/2019/05/019179尚未招募2 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 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients of either sex, 40 to 70 years of age.
- •2. 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
- •4. A minimum pain VAS score > 4 on walking in one or both knees during the 24 hours preceding recruitment.
- •5. Patient with or without receiving regular anti â?? inflammatory or analgesic drugs, or are not satisfied with drugs being taken and seek a change.
- •6. Willing to come for regular follow â?? up visits.
- •7. 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
- •6. Body mass index (BMI) >40 kg/m2.
- •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
研究者
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