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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Complex Ayurvedic Treatment
Conventional Care
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Osteoarthrosis, Arthritis, Arthrosis

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Charité Medical University Cooperation Center Sonne und Mond
  • Immanuel Krankenhaus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Complex Ayurvedic Treatment

Conventional Care

Arm 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.

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.

Outcomes

Primary Outcome Measures

Western Ontario and McMaster University Osteoarthritis Index (WOMAC)

Secondary Outcome Measures

Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales
SF-36-questionnaire
POMS-questionnaire
Visual Analogue Scales: Pain
Visual Analogue Scales: Sleep
Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales
SF-36-questionnaire
SF-36-questionnaire
Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales
POMS-questionnaire
POMS-questionnaire

Full Information

First Posted
October 6, 2010
Last Updated
March 30, 2015
Sponsor
Charite University, Berlin, Germany
Collaborators
Ministry of Health & Family Welfare, India
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1. Study Identification

Unique Protocol Identification Number
NCT01225133
Brief Title
Complex Āyurvedic Treatment in Osteoarthritis of the Knee Compared to Standard Care.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Ministry of Health & Family Welfare, India

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, Osteoarthrosis, Arthritis, Arthrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Complex Ayurvedic Treatment
Arm Type
Active Comparator
Arm 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.
Arm Title
Conventional Care
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Complex Ayurvedic Treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Care
Intervention 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.
Primary Outcome Measure Information:
Title
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales
Time Frame
month 6
Title
SF-36-questionnaire
Time Frame
week 12
Title
POMS-questionnaire
Time Frame
week 12
Title
Visual Analogue Scales: Pain
Time Frame
week 12
Title
Visual Analogue Scales: Sleep
Time Frame
week 12
Title
Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales
Time Frame
month 12
Title
SF-36-questionnaire
Time Frame
month 6
Title
SF-36-questionnaire
Time Frame
month 12
Title
Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales
Time Frame
week 12
Title
POMS-questionnaire
Time Frame
month 6
Title
POMS-questionnaire
Time Frame
month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Michalsen, Prof. Dr.
Organizational Affiliation
Charité Medical University Berlin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claudia M Witt, Prof. Dr.
Organizational Affiliation
Charité University Medical Center Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Medical University Cooperation Center Sonne und Mond
City
Berlin
ZIP/Postal Code
10119
Country
Germany
Facility Name
Immanuel Krankenhaus
City
Berlin
ZIP/Postal Code
14109
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
29426006
Citation
Kessler CS, Dhiman KS, Kumar A, Ostermann T, Gupta S, Morandi A, Mittwede M, Stapelfeldt E, Spoo M, Icke K, Michalsen A, Witt CM. Effectiveness of an Ayurveda treatment approach in knee osteoarthritis - a randomized controlled trial. Osteoarthritis Cartilage. 2018 May;26(5):620-630. doi: 10.1016/j.joca.2018.01.022. Epub 2018 Feb 7.
Results Reference
derived
PubMed Identifier
23701973
Citation
Witt CM, Michalsen A, Roll S, Morandi A, Gupta S, Rosenberg M, Kronpass L, Stapelfeldt E, Hissar S, Muller M, Kessler C. Comparative effectiveness of a complex Ayurvedic treatment and conventional standard care in osteoarthritis of the knee--study protocol for a randomized controlled trial. Trials. 2013 May 23;14:149. doi: 10.1186/1745-6215-14-149.
Results Reference
derived
Links:
URL
http://www.charite.de
Description
Charite Medical University

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

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