OsteoarthritisPhase 3CARAKANCT01225133
Complex Āyurvedic Treatment in Osteoarthritis of the Knee Compared to Standard Care.
A Phase 3 study testing Complex Ayurvedic Treatment and Conventional Care in people with Osteoarthritis, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Complex Ayurvedic Treatment and Conventional Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesGermany
- Study dates
- Oct 2010to Mar 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Charité Medical University Cooperation Center Sonne und Mond
Berlin, State of Berlin, 10119
Immanuel Krankenhaus
Berlin, State of Berlin, 14109
About this study
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.
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.
- Conditions
- Osteoarthritis
- Being tested
- Complex Ayurvedic Treatment, Conventional Care
- Keywords
- Osteoarthritis, Osteoarthrosis, Arthritis, Arthrosis
- Medical subject headings
- Osteoarthritis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Complex Ayurvedic Treatment; Other: 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. Receives: Other: Complex Ayurvedic Treatment; Other: Conventional Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Measured: week 12
Secondary outcomes (11)
Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales
Measured: month 6
SF-36-questionnaire
Measured: week 12
POMS-questionnaire
Measured: week 12
Visual Analogue Scales: Pain
Measured: week 12
Visual Analogue Scales: Sleep
Measured: week 12
Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales
Measured: month 12
SF-36-questionnaire
Measured: month 6
SF-36-questionnaire
Measured: month 12
Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales
Measured: week 12
POMS-questionnaire
Measured: month 6
POMS-questionnaire
Measured: month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJul 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Family Welfare, India
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
- Investigators
- Andreas Michalsen, Prof. Dr., Principal investigator, Charité Medical University BerlinClaudia M Witt, Prof. Dr., Principal investigator, Charité University Medical Center Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225133
- Sponsor's protocol ID
- CARAKA-1
- Acronym
- CARAKA
- Status last verified
- Mar 2015
- First submitted
- 6 Oct 2010
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
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 29426006Witt 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01225133
- Acronym / sponsor ID
- CARAKA / CARAKA-1
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Osteoarthrosis, Arthritis, Arthrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Ministry of Health & Family Welfare, India
- Study start
- Oct 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complex Ayurvedic Treatment | Active comparator | Other: Complex Ayurvedic Treatment, Other: Conventional CareIn 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. |
| Conventional Care | Active comparator | Other: Complex Ayurvedic Treatment, Other: Conventional CarePatients 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (17 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complex Ayurvedic TreatmentIn 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 | Complex Ayurvedic Treatment, Conventional Care |
| Conventional CarePatients 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, Conventional Care |
Primary outcome
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Time frame: week 12
11 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
- Derived from this study: PubMed 29426006Kessler 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.
- Derived from this study: PubMed 23701973Witt 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.
- Charite Medical UniversityLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Michalsen, Prof. Dr. principal investigator
Charité Medical University Berlin
Claudia M Witt, Prof. Dr. principal investigator
Charité University Medical Center Berlin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Complex Ayurvedic Treatment and Conventional Care in people with Osteoarthritis, run by Charite University, Berlin, Germany at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster University Osteoarthritis Index (WOMAC) (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01225133, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015.