NCT01225133

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2010

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 20, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

3.8 years

First QC Date

October 6, 2010

Last Update Submit

March 30, 2015

Conditions

Osteoarthritis

Keywords

Osteoarthritis, Osteoarthrosis, Arthritis, Arthrosis

Outcome Measures

Primary Outcomes (1)

  • Western Ontario and McMaster University Osteoarthritis Index (WOMAC)

    week 12

Secondary Outcomes (11)

  • Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales

    month 6

  • SF-36-questionnaire

    week 12

  • POMS-questionnaire

    week 12

  • Visual Analogue Scales: Pain

    week 12

  • Visual Analogue Scales: Sleep

    week 12

  • +6 more secondary outcomes

Study Arms (2)

Complex Ayurvedic Treatment

ACTIVE COMPARATOR

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 TreatmentOther: Conventional Care

Conventional Care

ACTIVE COMPARATOR

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 TreatmentOther: Conventional Care

Interventions

Complex Ayurvedic TreatmentOTHER

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.

Complex Ayurvedic TreatmentConventional Care
Conventional CareOTHER

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.

Complex Ayurvedic TreatmentConventional Care

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Charité Medical University Cooperation Center Sonne und Mond

Berlin, State of Berlin, 10119, Germany

Location

Immanuel Krankenhaus

Berlin, State of Berlin, 14109, Germany

Location

Related Publications (2)

  • 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.

    PMID: 29426006DERIVED

  • 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.

    PMID: 23701973DERIVED

Related Links

MeSH Terms

Conditions

OsteoarthritisArthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Andreas Michalsen, Prof. Dr.

    Charité Medical University Berlin

    PRINCIPAL INVESTIGATOR

  • Claudia M Witt, Prof. Dr.

    Charité University Medical Center Berlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Andreas Michalsen

Study Record Dates

First Submitted

October 6, 2010

First Posted

October 20, 2010

Study Start

October 1, 2010

Primary Completion

July 1, 2014

Study Completion

March 1, 2015

Last Updated

March 31, 2015

Record last verified: 2015-03

Locations

DE(2)