ArthralgiaPhase 3NCT04500210
Comparative Study of Turmeric Extract in Patients With Arthrosis.
A Phase 3 study testing Turmeric in people with Arthralgia and Stiffness of Unspecified Joint, Not Elsewhere Classified, run by Kaj Winther Hansen at 1 site in Denmark.
Trial summary
The aim of this study is to test if an extract of Turmeric can alleviate symptoms of osteoarthritis in volunteers with osteoarthritis of the hip and or knee. Read more about this study
- Who is it for?
- Ages 40 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthralgia, Stiffness of Unspecified Joint, Not Elsewhere Classified, Disturbance of Activity and Attention
- What is being tested?
- Turmeric
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2020to 7 Sep 2020
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Volunteers
- 40 years of age or more
- Osteoarthritis of the hip and or the knee
- Suffering from pain in the hip and or knee -
Who cannot join
- If volunteers are on a waiting list for hip or knee surgery
- If the volunteers are involved in an other clinical trial
- If the volunteers are taking other herbal remedies, which canhav influende on # Osteoarthritis.
- Abusers of alcohol and drugs
- Volunteers not easy to cope with
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports
Copenhagen, 1958 Frb. C
About this study
Official title: A Double-blind, Randomized, Parallel Group, Phase III Comparative Study of Turmeric Extract and Placebo to Patients With Mild to Moderate Arthrosis of the Knee and or Hip.
The aim of this study is to test if an extract of Turmeric can alleviate symptoms of osteoarthritis in volunteers with osteoarthritis of the hip and or knee.
Read the detailed description
The included volunteers, who are devided into two groups either placebo or turmeric extract, will be tested using WOMAC questionnaires focussing on pain, stiffness and daily activity. In addition different aspects of quality of life will be evaluated and the consumption of rescue medication will be recorded in patients personal diary.
The treatment period is 3 month with the posibility to continue for an additional 3 month.
- Conditions
- Arthralgia, Stiffness of Unspecified Joint, Not Elsewhere Classified, Disturbance of Activity and Attention, Quality of Life
- Being tested
- Placebo, Turmeric
- Keywords
- Arthralgia, stiffness of joints, quality of life
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Placebo in gelatin capsules
TurmericDietary supplement
Turmeric in gelatin capsules
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | one capsule daily Receives: Dietary Supplement: Placebo |
| Turmeric extract | Active comparator | one capsule daily Receives: Dietary Supplement: Turmeric |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Difference in WOMAC pain on a 100 mm VAS scale (high levels worse)
Measured: 3 month
Pain
Difference in WOMAC pain on a 100 mm VAS scale (high levels worse)
Measured: 6 month
ADL (Activity of daily living)
Difference in WOMAC ADL on a 100 mm VAS scale (high levels worse)
Measured: 3 month
ADL (Activity of daily living)
Difference in WOMAC ADL on a 100 mm VAS scale (high levels worse)
Measured: 6 month
Rescue medication
Consumption of rescue medication from diaries (mg)
Measured: 3 month
Rescue medication
Consumption of rescue medication from diaries (mg)
Measured: 6 month
Secondary outcomes (4)
Stiffness of joints
Difference in stiffness of joints on a 100 mm VAS scale (higher values worse)
Measured: 3 month
Stiffness of joints
Difference in stiffness of joints on a 100 mm VAS scale (higher values worse)
Measured: 6 month
The volunteer evaluation of Global Disease Severity (PGAD)
PGAD is measured on a 100 mm VAS scale (higher values worse)
Measured: 3 month
The volunteer evaluation of Global Disease Severity (PGAD)
PGAD is measured on a 100 mm VAS scale (higher values worse)
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start1 Jan 2020
- Primary completion7 Sep 2020
- Study completion7 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthralgiaStudies of the same condition, open and under way.
- 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
- Model description
- Half of the volunteers are given placebo and half of the volunteers are given Turmeric extract
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaj Winther Hansen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kaj Winther Hansen, University of Copenhagen
- Investigators
- Kaj W Hansen, Prof, DMSCi, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500210
- Sponsor's protocol ID
- Tr-01
- Status last verified
- Jul 2020
- First submitted
- 3 Jan 2020
- Last updated
- 25 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Parallel Group, Phase III Comparative Study of Turmeric Extract and Placebo to Patients With Mild to Moderate Arthrosis of the Knee and or Hip.
- ClinicalTrials.gov ID
- NCT04500210
- Acronym / sponsor ID
- Tr-01
- Conditions
- Arthralgia, Stiffness of Unspecified Joint, Not Elsewhere Classified, Disturbance of Activity and Attention, Quality of Life
- Keywords
- Arthralgia, stiffness of joints, quality of life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kaj Winther HansenUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 7 Sep 2020 (actual)
- Study completion
- 7 Sep 2020 (actual)
- First posted
- 5 Aug 2020 (actual)
- 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 test if an extract of Turmeric can alleviate symptoms of osteoarthritis in volunteers with osteoarthritis of the hip and or knee.
Detailed description
The included volunteers, who are devided into two groups either placebo or turmeric extract, will be tested using WOMAC questionnaires focussing on pain, stiffness and daily activity. In addition different aspects of quality of life will be evaluated and the consumption of rescue medication will be recorded in patients personal diary.
The treatment period is 3 month with the posibility to continue for an additional 3 month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Half of the volunteers are given placebo and half of the volunteers are given Turmeric extract
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placeboone capsule daily |
| Turmeric extract | Active comparator | Dietary Supplement: Turmericone capsule daily |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy Volunteers
- 40 years of age or more
- Osteoarthritis of the hip and or the knee
- Suffering from pain in the hip and or knee -
Key exclusion criteria (5 listed)
- If volunteers are on a waiting list for hip or knee surgery
- If the volunteers are involved in an other clinical trial
- If the volunteers are taking other herbal remedies, which canhav influende on # Osteoarthritis.
- Abusers of alcohol and drugs
- Volunteers not easy to cope with
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 |
|---|---|---|
| PlaceboPlacebo in gelatin capsules | Dietary supplement | Placebo |
| TurmericTurmeric in gelatin capsules | Dietary supplement | Turmeric extract |
Primary outcome
Pain
Time frame: 3 month
Difference in WOMAC pain on a 100 mm VAS scale (high levels worse)
Pain
Time frame: 6 month
Difference in WOMAC pain on a 100 mm VAS scale (high levels worse)
ADL (Activity of daily living)
Time frame: 3 month
Difference in WOMAC ADL on a 100 mm VAS scale (high levels worse)
ADL (Activity of daily living)
Time frame: 6 month
Difference in WOMAC ADL on a 100 mm VAS scale (high levels worse)
Rescue medication
Time frame: 3 month
Consumption of rescue medication from diaries (mg)
Rescue medication
Time frame: 6 month
Consumption of rescue medication from diaries (mg)
4 secondary outcomes
Stiffness of joints
Time frame: 3 month
Stiffness of joints
Time frame: 6 month
The volunteer evaluation of Global Disease Severity (PGAD)
Time frame: 3 month
The volunteer evaluation of Global Disease Severity (PGAD)
Time frame: 6 month
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 25 Oct 2021.
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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.
Kaj W Hansen, Prof, DMSCi principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Turmeric in people with Arthralgia and Stiffness of Unspecified Joint, Not Elsewhere Classified, run by Kaj Winther Hansen at 1 site in Denmark.
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 4 inclusion and 5 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 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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. Some participants in this study may receive a placebo. 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?
Pain (time frame: 3 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2021.