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Trial record 12 of 16 for:    +yoga+arthritis

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

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ClinicalTrials.gov Identifier: NCT01225133
Recruitment Status : Completed
First Posted : October 20, 2010
Last Update Posted : March 31, 2015
Sponsor:
Collaborator:
Ministry of Health & Family Welfare, India
Information provided by (Responsible Party):
Andreas Michalsen, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE October 6, 2010
First Posted Date  ICMJE October 20, 2010
Last Update Posted Date March 31, 2015
Study Start Date  ICMJE October 2010
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2010)
Western Ontario and McMaster University Osteoarthritis Index (WOMAC) [ Time Frame: week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01225133 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2010)
  • Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales [ Time Frame: month 6 ]
  • SF-36-questionnaire [ Time Frame: week 12 ]
  • POMS-questionnaire [ Time Frame: week 12 ]
  • Visual Analogue Scales: Pain [ Time Frame: week 12 ]
  • Visual Analogue Scales: Sleep [ Time Frame: week 12 ]
  • Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales [ Time Frame: month 12 ]
  • SF-36-questionnaire [ Time Frame: month 6 ]
  • SF-36-questionnaire [ Time Frame: month 12 ]
  • Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales [ Time Frame: week 12 ]
  • POMS-questionnaire [ Time Frame: month 6 ]
  • POMS-questionnaire [ Time Frame: month 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Complex Āyurvedic Treatment in Osteoarthritis of the Knee Compared to Standard Care.
Official Title  ICMJE 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.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: Complex Ayurvedic Treatment
    • Other: Conventional Care
  • 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.
    Interventions:
    • Other: Complex Ayurvedic Treatment
    • Other: Conventional Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2010)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01225133
Other Study ID Numbers  ICMJE CARAKA-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andreas Michalsen, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Ministry of Health & Family Welfare, India
Investigators  ICMJE
Principal Investigator: Andreas Michalsen, Prof. Dr. Charité Medical University Berlin
Principal Investigator: Claudia M Witt, Prof. Dr. Charité University Medical Center Berlin
PRS Account Charite University, Berlin, Germany
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP