IRCT20220614055167N2尚未招募1 期
The Joint Effects of Turmeric, Black Seeds, Flaxseed and Medicago Sativa for relieving symptoms of knee osteoarthritis: A Phase 1-2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
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
- 年龄范围
- 40 years 至 no limit(—)
- 性别
- All
入选标准
- •At least 6 months of diagnosis of knee osteoarthritis, and whose OA diagnosis meets the American College of Rheumatology criteria
- •Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale baseline value of = 9 (0-20 scale)
- •Functional Capacity Classification of I-III
- •Radiograph evidence of OA in the target knee with a Kellgren-Lawrence score of 2 or 3
- •Morning stiffness of <30 min duration or crepitus on active motion, which is present upon examination
排除标准
- •Evidence of other conditions or diseases of the skin or joints
- •Evidence of partial or complete knee joint replacement or anticipated joint replacement in the target knee
- •Contraindications to the use of non-steroidal anti-inflammatory drugs (NSAIDs) or who use anticoagulant therapy that prohibits them from using NSAIDs
- •Pregnancy, planning to become pregnant or breastfeeding during the study period
- •Ischemic heart disease, heart failure, end-stage cirrhosis, end-stage renal failure, or psychiatric conditions that prevent an adequate evaluation of the study outcomes
- •Insufficient cognitive functioning to participate and complete the questionnaires
- •Unable or unwilling to follow up and complete the study pathway,
- •A history or diagnosis of other arthritic conditions, such as rheumatoid arthritis, joint and bone deformities, fibromyalgia and/or other inflammatory and immune system disorders
- •Type I or II diabetes or obesity (body mass index = 39)
- •Suffering from painful conditions or frequent headaches requiring the use of systemic opiates or derivatives, or the need for additional NSAID or COX-2 inhibitors
- •Receiving systemic or intra-articular corticosteroid injections.
- •Having active cancer undergoing treatment that prevents the evaluation of the outcome measures
研究者
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