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

Charité University Medicine Berlin

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis

Treatments: Other: Conventional Care; Other: Complex Ayurvedic Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01225133

CARAKA-1

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Complex Ayurvedic Treatment

Active Comparator group

Description:

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.

Treatment:

Other: Conventional Care

Other: Complex Ayurvedic Treatment

Conventional Care

Active Comparator group

Description:

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.

Treatment:

Other: Conventional Care

Other: Complex Ayurvedic Treatment