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

Osteoarthritis Clinical Trial

— CARAKA  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01225133
• Other study ID #: CARAKA-1
• Status: Completed
• Phase: Phase 3
• First received: October 6, 2010
• Last updated: March 30, 2015
• Start date: October 2010
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Complex Ayurvedic Treatment
In the Ayurveda group treatment will be individualized according to the Ayurveda diagnosis and include manual treatments, massages, dietary advice, specific consideration of selected food items, nutritional supplements, ayurvedic lifestyle and yoga posture advice and daily self-applied knee massage.
• 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.

Locations

Country	Name	City	State
Germany	Charité Medical University Cooperation Center Sonne und Mond	Berlin
Germany	Immanuel Krankenhaus	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Ministry of Health & Family Welfare, India

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario and McMaster University Osteoarthritis Index (WOMAC)		week 12	No
Secondary	Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales		month 6	No
Secondary	SF-36-questionnaire		week 12	No
Secondary	POMS-questionnaire		week 12	No
Secondary	Visual Analogue Scales: Pain		week 12	No
Secondary	Visual Analogue Scales: Sleep		week 12	No
Secondary	Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales		month 12	No
Secondary	SF-36-questionnaire		month 6	No
Secondary	SF-36-questionnaire		month 12	No
Secondary	Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales		week 12	No
Secondary	POMS-questionnaire		month 6	No
Secondary	POMS-questionnaire		month 12	No

External Links

•   Charite Medical University