NCT01389336已完成不适用
Kontrollierte Klinische Nicht-randomisierte Pilotstudie Zur Komplexen Āyurveda-Therapie Beim Fibromyalgiesyndrom im Vergleich Zur Konventionellen Standardbehandlung
Andreas Michalsen1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2011年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Fibromyalgia Impact Questionnaire (FIQ)
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of an additive complex āyurvedic diagnosis and treatment compared to conventional standard care alone in stationary patients with Fibromyalgia Syndrome.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed consent
- •age between 18 and 70 years
- •FMS according to current guidelines
排除标准
- •change of pharmacological FMS treatment >= 6 weeks before inclusion
- •pregnancy or breat feeding
- •acute psychiatric condition
- •severe acute somatic disease
- •severechronic comorbidity
- •obesity WHO >= II degree
- •bloodcoagulation-disease
- •intake of opiods
- •current treatment with hyperthermia
- •simultaneous participant in other trial
- •praticipation in other trial during 6 month before inclusion
结局指标
主要结局
Fibromyalgia Impact Questionnaire (FIQ)
时间窗: max. 3 weeks
Change in FIQ after completion of IPD-treatment
次要结局
- Functional Hanover Questionnaire (FFBH)(max. 3 weeks)
- State Trait Anxiety Inventory (STAI)(max. 3 weeks)
- Profile of Mood States (POMS)(max. 3 weeks)
- Short Form 36 Health Survey (SF-36)(max. 3 weeks)
- VAS for pain(max 3 weeks)
- Likert-Scales(max 3 weeks)
- FIQ(6 month)
- FFBH, STAI, POMS, SF-36, VAS, Likert-Scales.(6 month)
研究者
Andreas Michalsen
Prof. Dr. Andreas Michalsen
Charite University, Berlin, Germany
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Complex Āyurvedic Treatment in Osteoarthritis of the Knee Compared to Standard Care.OsteoarthritisNCT01225133Charite University, Berlin, Germany150
已完成
不适用
Ayurvedic Management of Chronic Kidney DiseaseHypertensive NephropathyDiabetic NephropathyNCT02477163J.S. Ayurveda College521
尚未招募
Unknown
Ayurveda diagnostic algorithm for chronic kidney diseaseCTRI/2024/05/067083All India Institute of Ayurveda
已完成
2 期
Treatment of Pakshaghat(Hemiplegia according to modern medicine) with multimodal ayurvedic treatment(oral medicines and panchakarma procedures).CTRI/2018/12/016808J S Ayurveda Mahavidyalaya17
已完成
不适用
Specific Acupuncture Protocol for the Treatment of Plantar FasciosisPlantar FascitisNCT04243343brett rasmussen72