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

Phase 3

Completed

• Conditions: Osteoarthritis
• Interventions: Other: Complex Ayurvedic Treatment; Other: Conventional Care

• 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

Arm && Interventions

Group	Intervention	Description
Conventional Care	Complex Ayurvedic Treatment	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.
Conventional Care	Conventional Care	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.
Complex Ayurvedic Treatment	Complex Ayurvedic Treatment	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.
Complex Ayurvedic Treatment	Conventional Care	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scales: Sleep	week 12
SF-36-questionnaire	month 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)

Immanuel Krankenhaus; 🇩🇪 Berlin, Germany

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