PainPhase 4NCT01073982
Efficacy of Tart Cherry Juice to Reduce Pain and Inflammation Among Patients With Inflammatory Osteoarthritis
A Phase 4 study testing tart cultivar Montmorency cherry juice in people with Pain and Inflammation, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to assess the effects of tart cherry juice to reduce pain and inflammation among individuals with arthritis. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Pain, Inflammation
- What is being tested?
- tart cultivar Montmorency cherry juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Jan 2011
- Phase
- Phase 4
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with inflammatory osteoarthritis
- In good general health
- Stable pattern of anti-inflammatory or pain relieving drug use for 3 months prior to study
- Ability and willingness to maintain consistent pattern of anti-inflammatory or pain relieving drug use during the course of the study, and to not seek any other treatment during the study
- Ability and willingness to consume juice or placebo drink for 21 consecutive days, and to participate in screening measures, including a blood draw, before and after the intervention period
Who cannot join
- Pregnancy
- Serious medical conditions such as recent heart attack or stroke, cancer, diabetes (type 1 and type 2), or gastrointestinal ulcers
- Individuals who have not been on a stable dose of pain medications or pain modalities for at least 3 months, including muscle relaxants, tender point anesthetic injections, systemic or intrabursal or intraarticular steroids, or any investigational drug/device in the prior 90 days
- Individuals who have used nonpharmacologic pain therapies including acupuncture, ultrasound, or transcutaneous electrical nerve stimulation within the past 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
The purpose of this study is to assess the effects of tart cherry juice to reduce pain and inflammation among individuals with arthritis.
Read the detailed description
Numerous antioxidant and anti-inflammatory agents have been identified in tart cherries, and a study among healthy, non-exercising individuals demonstrated that cherry consumption decreased serum inflammatory biomarkers after 14 days. Osteoarthritis (OA) is a common syndrome affecting 65 million Americans characterized by pain, inflammation, and disability. Such natural anti-inflammatory effects of cherry consumption may be beneficial for the management and treatment of osteoarthritis and inflammatory diseases. The purpose of this randomized, double-blind, placebo controlled study is to examine individuals with inflammatory OA and assess the analgesic and anti-inflammatory effects of tart cherry juice as compared to a placebo drink among twenty 30-70 y/o OA subjects.
- Conditions
- Pain, Inflammation
- Being tested
- tart cultivar Montmorency cherry juice
- Keywords
- pain, inflammation, osteoarthritis
- Medical subject headings
- Pain, Inflammation, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tart cultivar Montmorency cherry juiceDietary supplement
21 ounces of experimental or placebo juice, consumed daily for 21 days.
| Study group | Role | What they receive |
|---|---|---|
| cherry flavored fruit drink | Placebo comparator | Not described Receives: Dietary Supplement: tart cultivar Montmorency cherry juice |
| tart cherry juice | Experimental | Not described Receives: Dietary Supplement: tart cultivar Montmorency cherry juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcomes include measurement of interleukin 10 (IL-10), CRP, and a specific group of cytokines that provide a generalized measurement of inflammatory activity, these include IL-6 and TNF-α.
Measured: 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Cherry Research Committee
- Investigators
- Kerry S Kuehl, MD, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073982
- Sponsor's protocol ID
- e5825
- Status last verified
- Jan 2011
- First submitted
- 12 Feb 2010
- Last updated
- 20 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tart Cherry Juice to Reduce Pain and Inflammation Among Patients With Inflammatory Osteoarthritis
- ClinicalTrials.gov ID
- NCT01073982
- Acronym / sponsor ID
- e5825
- Conditions
- Pain, Inflammation
- Keywords
- pain, inflammation, osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Cherry Research Committee
- Study start
- Feb 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 24 Feb 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 purpose of this study is to assess the effects of tart cherry juice to reduce pain and inflammation among individuals with arthritis.
Detailed description
Numerous antioxidant and anti-inflammatory agents have been identified in tart cherries, and a study among healthy, non-exercising individuals demonstrated that cherry consumption decreased serum inflammatory biomarkers after 14 days. Osteoarthritis (OA) is a common syndrome affecting 65 million Americans characterized by pain, inflammation, and disability. Such natural anti-inflammatory effects of cherry consumption may be beneficial for the management and treatment of osteoarthritis and inflammatory diseases. The purpose of this randomized, double-blind, placebo controlled study is to examine individuals with inflammatory OA and assess the analgesic and anti-inflammatory effects of tart cherry juice as compared to a placebo drink among twenty 30-70 y/o OA subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cherry flavored fruit drink | Placebo comparator | Dietary Supplement: tart cultivar Montmorency cherry juice |
| tart cherry juice | Experimental | Dietary Supplement: tart cultivar Montmorency cherry juice |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with inflammatory osteoarthritis
- In good general health
- Stable pattern of anti-inflammatory or pain relieving drug use for 3 months prior to study
- Ability and willingness to maintain consistent pattern of anti-inflammatory or pain relieving drug use during the course of the study, and to not seek any other treatment during the study
- Ability and willingness to consume juice or placebo drink for 21 consecutive days, and to participate in screening measures, including a blood draw, before and after the intervention period
Key exclusion criteria (4 listed)
- Pregnancy
- Serious medical conditions such as recent heart attack or stroke, cancer, diabetes (type 1 and type 2), or gastrointestinal ulcers
- Individuals who have not been on a stable dose of pain medications or pain modalities for at least 3 months, including muscle relaxants, tender point anesthetic injections, systemic or intrabursal or intraarticular steroids, or any investigational drug/device in the prior 90 days
- Individuals who have used nonpharmacologic pain therapies including acupuncture, ultrasound, or transcutaneous electrical nerve stimulation within the past 30 days
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 |
|---|---|---|
| tart cultivar Montmorency cherry juice21 ounces of experimental or placebo juice, consumed daily for 21 days. | Dietary supplement | cherry flavored fruit drink, tart cherry juice |
Primary outcome
Primary outcomes include measurement of interleukin 10 (IL-10), CRP, and a specific group of cytokines that provide a generalized measurement of inflammatory activity, these include IL-6 and TNF-α.
Time frame: 6-8 months
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 20 Jan 2011.
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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.
Kerry S Kuehl, MD, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tart cultivar Montmorency cherry juice in people with Pain and Inflammation, run by Oregon Health and Science University at 1 site in United States.
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 5 inclusion and 4 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 20 Jan 2011. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Primary outcomes include measurement of interleukin 10 (IL-10), CRP, and a specific group of cytokines that provide a generalized measurement of inflammatory activity, these include IL-6 and TNF-α. (time frame: 6-8 months). 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 20 Jan 2011.