Clinical trial NCT01225133: Complex Āyurvedic Treatment in Osteoarthritis of the Knee Compared to Standard Care.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Osteoarthritis, Osteoarthrosis, Arthritis, Arthrosis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Family Welfare, India
First posted: 2010-10-20
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
timeFrame: week 12
Secondary outcomes:
measure: Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales
timeFrame: month 6
measure: SF-36-questionnaire
timeFrame: week 12
measure: POMS-questionnaire
timeFrame: week 12
measure: Visual Analogue Scales: Pain
timeFrame: week 12
measure: Visual Analogue Scales: Sleep
timeFrame: week 12
measure: Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales
timeFrame: month 12
measure: SF-36-questionnaire
timeFrame: month 6
measure: SF-36-questionnaire
timeFrame: month 12
measure: Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales
timeFrame: week 12
measure: POMS-questionnaire
timeFrame: month 6
measure: POMS-questionnaire
timeFrame: month 12
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Medical University Cooperation Center Sonne und Mond
city: Berlin
country: Germany
facility: Immanuel Krankenhaus
Study officials:
affiliation: Charité Medical University Berlin
name: Andreas Michalsen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Charité University Medical Center Berlin
name: Claudia M Witt, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kessler CS, Dhiman KS, Kumar A, Ostermann T, Gupta S, Morandi A, Mittwede M, Stapelfeldt E, Spoo M, Icke K, Michalsen A, Witt CM. Effectiveness of an Ayurveda treatment approach in knee osteoarthritis - a randomized controlled trial. Osteoarthritis Cartilage. 2018 May;26(5):620-630. doi: 10.1016/j.joca.2018.01.022. Epub 2018 Feb 7.
citation: Witt CM, Michalsen A, Roll S, Morandi A, Gupta S, Rosenberg M, Kronpass L, Stapelfeldt E, Hissar S, Muller M, Kessler C. Comparative effectiveness of a complex Ayurvedic treatment and conventional standard care in osteoarthritis of the knee--study protocol for a randomized controlled trial. Trials. 2013 May 23;14:149. doi: 10.1186/1745-6215-14-149.