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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ministry of Health & Family Welfare, India
Information provided by (Responsible Party):
Andreas Michalsen, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01225133
First received: October 6, 2010
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Other: Complex Ayurvedic Treatment
Other: Conventional Care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Western Ontario and McMaster University Osteoarthritis Index (WOMAC) [ Time Frame: week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • SF-36-questionnaire [ Time Frame: week 12 ] [ Designated as safety issue: No ]
  • POMS-questionnaire [ Time Frame: week 12 ] [ Designated as safety issue: No ]
  • Visual Analogue Scales: Pain [ Time Frame: week 12 ] [ Designated as safety issue: No ]
  • Visual Analogue Scales: Sleep [ Time Frame: week 12 ] [ Designated as safety issue: No ]
  • Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • SF-36-questionnaire [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • SF-36-questionnaire [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales [ Time Frame: week 12 ] [ Designated as safety issue: No ]
  • POMS-questionnaire [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • POMS-questionnaire [ Time Frame: month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: October 2010
Estimated Study Completion Date: April 2015
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Other: Complex Ayurvedic Treatment
In the Āyurveda group 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.
Other: 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.
Active Comparator: 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.
Other: Complex Ayurvedic Treatment
In the Āyurveda group 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.
Other: 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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225133

Locations
Germany
Immanuel Krankenhaus
Berlin, Germany, 14109
Charité Medical University Cooperation Center Sonne und Mond
Berlin, Germany, 10119
Sponsors and Collaborators
Charite University, Berlin, Germany
Ministry of Health & Family Welfare, India
Investigators
Principal Investigator: Andreas Michalsen, Prof. Dr. Charité Medical University Berlin
Principal Investigator: Claudia M Witt, Prof. Dr. Charité University Medical Center Berlin
  More Information

Additional Information:
No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andreas Michalsen, Prof. Dr. med. Andreas Michalsen, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01225133     History of Changes
Other Study ID Numbers: CARAKA-1
Study First Received: October 6, 2010
Last Updated: July 17, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
Osteoarthritis, Osteoarthrosis, Arthritis, Arthrosis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 20, 2014