Skip to main content
OpenTrials
Completed

NCT Number: NCT01225133

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Charité Medical University Cooperation Center Sonne und Mond, Berlin, State of Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Complex Ayurvedic Treatment

Other

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.

Conventional care

Other

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 outcomes

  1. Western Ontario and McMaster University Osteoarthritis Index (WOMAC)

    Time frame: week 12

Secondary outcomes

  1. Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales

    Time frame: month 6

  2. SF-36-questionnaire

    Time frame: week 12

  3. POMS-questionnaire

    Time frame: week 12

  4. Visual Analogue Scales: Pain

    Time frame: week 12

  5. Visual Analogue Scales: Sleep

    Time frame: week 12

  6. Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales

    Time frame: month 12

  7. SF-36-questionnaire

    Time frame: month 6

  8. SF-36-questionnaire

    Time frame: month 12

  9. Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales

    Time frame: week 12

  10. POMS-questionnaire

    Time frame: month 6

  11. POMS-questionnaire

    Time frame: month 12

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Ministry of Health & Family Welfare, India

Registry information

Official study 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.

Acronym: CARAKA

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Oct 20, 2010
Registry last updated
Mar 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.