Status:
COMPLETED
Complex Āyurvedic Treatment in Osteoarthritis of the Knee Compared to Standard Care.
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Ministry of Health & Family Welfare, India
Conditions:
Osteoarthritis
Eligibility:
All Genders
40-70 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01225133
Start Date
October 1 2010
End Date
March 1 2015
Last Update
March 31 2015
Active Locations (2)
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1
Charité Medical University Cooperation Center Sonne und Mond
Berlin, State of Berlin, Germany, 10119
2
Immanuel Krankenhaus
Berlin, State of Berlin, Germany, 14109