ISRCTN58050062进行中（未招募）未知
Two arm open-label noninferiority randomized control clinical trial for comparing the efficacy and safety of Sri Lankan traditional medicine regimen for knee osteoarthritis
niversity of Colombo0 个研究点目标入组 140 人开始时间: 2021年8月3日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
研究概览
简要总结
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36415006/ (added 28/11/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Diagnosis and classification of knee osteoarthritis (KOA) based on history, clinical examination findings, and classical radiological findings as follows:
- •1. The three American College of Rheumatology (ACR) classification criteria for the knee shown below, but for this study the lower age limit will be reduced from 50 years to 40 years:
- •1.1.ACR Clinical classification criteria, where KOA is classified by the presence of knee pain along with at least three of the following six items:
- •1.1.1. Aged >50 years
- •1.1.2. Morning stiffness <30 min
- •1.1.3. Crepitus on knee motion
- •1.1.4. Bony tenderness
- •1.1.5. Bony enlargement
- •1.1.6. No palpable warmth
- •1.2. ACR Clinical/Radiographic classification criteria, where KOA is classified by the presence of knee pain with at least one of the following three items along with osteophyte in knee X-Ray:
- •1.2.1. Aged >50 years
- •1.2.2. Morning stiffness <30 min
- •1.2.3. Crepitus on knee motion
- •1.3. ACR Clinical/Laboratory classification criteria, where KOA is classified by the presence of knee pain along with at least 5 of the following 9 items:
- •1.3.1. Aged >50 years
- •1.3.2. Morning stiffness <30 min
- •1.3.3. Crepitus on knee motion
- •1.3.4. Bony tenderness
- •1.3.5. Bony enlargement
- •1.3.6. No palpable warmth
- •1.3.7. Rheumatoid Factor <1:40
- •1.3.8. Erythrocyte sedimentation rate (ESR) <40 mm/h
- •1.3.9. Synovial fluid compatible with OA
- •2. Visual Analogue Score (VAS) for pain mean pain intensity in one or both knees of =40 mm on a 100 mm while performing a weight-bearing activity (walking, standing, or climbing a staircase) over the 7 days before baseline assessment. The VAS used will be a five-point Likert scale version with five response levels for each item, representing different degrees of intensity: None (0), mild (1), moderate (2), severe (3), and extreme (4).
- •3. Radiographic evidence of OA grades 1-3 assessed using the ranking score of the Kellgren-Lawrence radiographic system (0-4)
排除标准
- •1. Non-degenerative joint diseases or other joint diseases such as rheumatoid arthritis, psoriatic arthritis, gonococcal arthritis, and haemoarthritis
- •2. Severe disabling arthritis and/or are bedridden
- •3. History of intra-articular knee injection within the month preceding the study
- •4. Evidence of severe unstable cancer, hypertension, cardiac disorder, mental health disorder, or renal, hepatic, diabetic, or haemopoietic disease revealed by history and/or investigation
- •5. Concurrent anticoagulant/antiplatelet drugs, corticosteroids, or narcotic pain killers use
- •6. History of epilepsy or bleeding disorders, gastric ulcers, renal or hepatic disease, uncontrolled hypertension, or body mass index (BMI) >45 kg/m²
- •7. A washout period of 7 days is required for NSAID users
- •8. Discontinuing the use of common complementary and alternative therapies for arthritis (e.g. glucosamine, chondroitin sulfate, bromelain, DMSO, acupuncture, and Ayurveda medicine) is required for 7 days prior to enrollment
- •9. Written informed consent to participate in the study not provided
研究者
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