CClinicalTrials.gg
Sign In
CompletedNCT01225133CARAKAUpdated Mar 31, 2015

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

A Phase 3 interventional study of Complex Ayurvedic Treatment and Conventional Care in Osteoarthritis, sponsored by Charite University, Berlin, Germany. Completed at 2 sites in Germany. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-03-31.

Sponsored by Charite University, Berlin, Germany · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Osteoarthritis

Keywords

  • Osteoarthritis, Osteoarthrosis, Arthritis, Arthrosis
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 150 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • 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 · 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.

    Other: Complex Ayurvedic Treatment · Other: Conventional Care

Interventions

  • OtherComplex 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.

  • OtherConventional 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.

06

What researchers measure

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

07

Study locations

2 sites
  • Charité Medical University Cooperation Center Sonne und Mond
    Berlin, 10119, Germany
  • Immanuel Krankenhaus
    Berlin, 14109, Germany
08

References and documents

Publications

  • 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. PubMed 29426006 ↗
  • 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. PubMed 23701973 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01225133
Lead sponsor
Charite University, Berlin, Germany
Collaborators
Ministry of Health & Family Welfare, India
Responsible party
Andreas Michalsen (Prof. Dr. med. Andreas Michalsen, Charite University, Berlin, Germany) — Principal investigator
First posted
Oct 20, 2010
Start date
Oct 2010
Primary completion
Jul 2014
Completion
Mar 2015
Last update
Mar 31, 2015

Study contacts

Andreas Michalsen, Prof. Dr.
principal investigator · Charité Medical University Berlin
Claudia M Witt, Prof. Dr.
principal investigator · Charité University Medical Center Berlin

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Osteoarthritis→

Other studies from this sponsor

Charite University, Berlin, Germany

Start the discussion