The CARAKA-Trial: Complex Āyurvedic Treatment in Osteoarthritis of the Knee Against Standard Care.A Multicentre, Randomized, Controlled Clinical Trial Based on Traditional Āyurveda-Diagnosis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of a complex āyurvedic diagnosis and treatment compared to conventional standard care in patients with OA of the knee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients,
- •Age 40-70 years,
- •Prediagnosed, confirmed and documented diagnosis of OA of the knee. Diagnosis performed by a medical specialist (orthopedic surgeon, surgeon, radiologist) according to the American College of Rheumatology criteria,
- •Documented radiologic changes of the knee-joint Kellgren-Lawrence criteria > or = grade 2 in conventional X-ray or MRI-scan,
- •Mean average pain intensity of 40 or more on two 100 mm visual analogue scales in the 7 days before baseline assessment,
- •Written informed consent.
排除标准
- •Pain in the knee caused by oCongenital dysplasia of the affected knee oRheumatoid arthritis oAutoimmune diseases oMalignancies oStatus post Knee surgery oStatus post Arthroscopy
- •Administration of chondroprotective drugs in the preceding 3 months,
- •Intra-articular injection into the affected knee-joint during the preceding 3 months,
- •Beginning of a systemic medication with corticosteroids within the preceding three months,
- •Beginning of any new treatment for OA during the previous 4 weeks (with the exception of analgesic treatment with Paracetamol or NSAIDs),
- •Pregnancy or breastfeeding,
- •Acute mental disorders,
- •Serious acute organic diseases,
- •Serious chronic co-morbidity,
- •Obesity WHO-grade II/III
- •Blood coagulation disorders,
- •Coagulation-inhibiting medication other than Aspirin and Clopidogrel,
- •Invasive measures performed at the affected joint during the previous 12 weeks or planned within the following 12 month,
- •In the process of applying for pension or disability benefits,
- •Simultaneous participation in any other clinical trial,
- •Participation in a clinical trial during the 6 month before inclusion into this trial,
- •Missing of the written informed consent form.
研究组 & 干预措施
Complex Ayurvedic Treatment
In the Āyurveda arm treatment will be individualized according to the Āyurveda diagnosis and include manual treatments, massages, dietary advice, specific consideration of selected food items, nutritional supplements, āyurvedic lifestyle and yoga posture advice and daily self-applied knee massage.
干预措施: Complex Ayurvedic Treatment (Other)
Complex Ayurvedic Treatment
In the Āyurveda arm treatment will be individualized according to the Āyurveda diagnosis and include manual treatments, massages, dietary advice, specific consideration of selected food items, nutritional supplements, āyurvedic lifestyle and yoga posture advice and daily self-applied knee massage.
干预措施: Conventional Care (Other)
Conventional Care
Patients in the conventional standard care group will receive conventional standard care for OA of the Knee which includes self care advice, pain medication and intensified physiotherapy and follows the current international guidelines for OA of the knee.
干预措施: Complex Ayurvedic Treatment (Other)
Conventional Care
Patients in the conventional standard care group will receive conventional standard care for OA of the Knee which includes self care advice, pain medication and intensified physiotherapy and follows the current international guidelines for OA of the knee.
干预措施: Conventional Care (Other)
结局指标
主要结局
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
时间窗: week 12
次要结局
- SF-36-questionnaire(month 12)
- Visual Analogue Scales: Sleep(week 12)
- Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales(week 12)
- POMS-questionnaire(month 12)
- Visual Analogue Scales: Pain(week 12)
研究者
Andreas Michalsen
Prof. Dr. med. Andreas Michalsen
Charite University, Berlin, Germany