Complex Āyurvedic Treatment in Osteoarthritis of the Knee Compared to Standard Care.

Phase 3

Completed

• Conditions: Osteoarthritis

• Registration Number: NCT01225133
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-06
• Study First Submitted QC: 2010-10-19
• Study First Posted: 2010-10-20
• Primary Completion: 2014-07
• Status Verified: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)	week 12

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Charité Medical University Cooperation Center Sonne und Mond; 🇩🇪 Berlin, Germany

Immanuel Krankenhaus; 🇩🇪 Berlin, Germany