OsteoarthritisPhase 4NCT00443092
Efficacy of Proprietary Cherry Juice Blend in Osteoarthritis of the Knee
A Phase 4 study testing proprietary cherry juice blend (food) in people with Osteoarthritis, run by CherryPharm at 1 site in United States.
Trial summary
The primary purpose of this research study is to test the ability of a proprietary cherry juice blend to be helpful in the treatment of osteoarthritis (OA) of the knee. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- proprietary cherry juice blend (food)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Dec 2010
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is capable of giving informed consent.
- Subject is over 18 years and less than 80 years
- Subject has mild to moderate osteoarthritis of the knee based on all of the following 3:
- Meets clinical ACR criteria
- Kellgren score of 2-3 on a Standing Knee x-ray within previous 24 months
- VAS pain score of 4-9 at screening visit
Who cannot join
- Rheumatoid arthritis or other systemic inflammatory condition
- Chronic pain syndrome (fibromyalgia)
- Corticosteroid medication in last 2 months, either intra-articular or oral
- Intra-articular injections of hyaluronic acid in last 9 months
- Pregnant women (weight gain might confound degree of knee pain)
- Diabetes
Show all 9Show fewer
- Inability to discontinue prescription medication for arthritis
- Unstable medical conditions that would likely prevent the subject from completing the study
- Food allergies - cherries, apples
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind Cross-over Study of the Efficacy of a Proprietary Cherry Juice Blend in Osteoarthritis of the Knee.
The primary purpose of this research study is to test the ability of a proprietary cherry juice blend to be helpful in the treatment of osteoarthritis (OA) of the knee.
Read the detailed description
The primary objective is to determine if the proprietary tart cherry juice blend improves the pain and function in persons with knee osteoarthritis. A secondary objective is to ascertain if the blend lowers serum uric acid.
This is a prospective double blind, placebo controlled cross-over study.
The study will be performed in the Philadelphia VA Medical Center 1 South Rheumatology Clinic with patients meeting ACR criteria for Kellgren grade 2-3 knee osteoarthritis and 4-9 pain severity on a VAS. Fifty patients will be studied with each having 5 visits. Subjects will take either the proprietary cherry blend or placebo for 6 weeks and then switch. WOMAC pain and function will be the primary outcome with acetaminophen use, walking time and serum uric acid as secondary outcomes.
- Conditions
- Osteoarthritis
- Being tested
- proprietary cherry juice blend (food), control juice (kool aid blend)
- Keywords
- osteoarthritis, gout, pain, uric acid, tart cherry, alternative medicine, knees
- Medical subject headings
- Osteoarthritis, Gout, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proprietary cherry juice blend (food)Other
2 bottles per day for 6 weeks, 1 in the morning and 1 in the evening
control juice (kool aid blend)Other
2 bottles per day for 6 weeks, 1 in the morning and 1 in the evening
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | proprietary tart cherry juice blend (8 oz., BID) Receives: Other: proprietary cherry juice blend (food) |
| 2 | Placebo comparator | control juice (color matched kool aid blend),(8 oz., BID) Receives: Other: control juice (kool aid blend) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Western Ontario McMaster Osteoarthritis Index (WOMAC) Scores to be taken at Visits 2-5.
Measured: Visit 3 (week 6-7), Visit 5 (week 13-14)
Secondary outcomes (2)
Determine if there is a decrease in amount of non-prescription pain medication taken and/or improvement in score on a timed walking test (Visits 2,3,4,5).
Measured: Visit 3 (week 6-7), Visit 5 (week 13-14)
Determine if there is a decrease in serum uric acid levels. (Visits 1,3,5)
Measured: Visit 3 (week 6-7), Visit 5 (week 13-14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionJun 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- CherryPharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- H. R Schumacher, M.D., Principal investigator, VA Medical Center, Philadelphia & University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443092
- Sponsor's protocol ID
- CP100M
- Other IDs
- VA MIRB ID # 00981
- Status last verified
- Aug 2012
- First submitted
- 2 Mar 2007
- Last updated
- 3 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
BLAU LW. Cherry diet control for gout and arthritis. Tex Rep Biol Med. 1950;8(3):309-11. No abstract available.
PubMed 14776685Connolly DA, McHugh MP, Padilla-Zakour OI, Carlson L, Sayers SP. Efficacy of a tart cherry juice blend in preventing the symptoms of muscle damage. Br J Sports Med. 2006 Aug;40(8):679-83; discussion 683. doi: 10.1136/bjsm.2005.025429. Epub 2006 Jun 21.
PubMed 16790484Seeram NP, Momin RA, Nair MG, Bourquin LD. Cyclooxygenase inhibitory and antioxidant cyanidin glycosides in cherries and berries. Phytomedicine. 2001 Sep;8(5):362-9. doi: 10.1078/0944-7113-00053.
PubMed 11695879He YH, Zhou J, Wang YS, Xiao C, Tong Y, Tang JC, Chan AS, Lu AP. Anti-inflammatory and anti-oxidative effects of cherries on Freund's adjuvant-induced arthritis in rats. Scand J Rheumatol. 2006 Sep-Oct;35(5):356-8. doi: 10.1080/03009740600704155.
PubMed 17062434Jacob RA, Spinozzi GM, Simon VA, Kelley DS, Prior RL, Hess-Pierce B, Kader AA. Consumption of cherries lowers plasma urate in healthy women. J Nutr. 2003 Jun;133(6):1826-9. doi: 10.1093/jn/133.6.1826.
PubMed 12771324Pincus T, Koch G, Lei H, Mangal B, Sokka T, Moskowitz R, Wolfe F, Gibofsky A, Simon L, Zlotnick S, Fort JG. Patient Preference for Placebo, Acetaminophen (paracetamol) or Celecoxib Efficacy Studies (PACES): two randomised, double blind, placebo controlled, crossover clinical trials in patients with knee or hip osteoarthritis. Ann Rheum Dis. 2004 Aug;63(8):931-9. doi: 10.1136/ard.2003.020313. Epub 2004 Apr 13.
PubMed 15082468Johanson NA, Liang MH, Daltroy L, Rudicel S, Richmond J. American Academy of Orthopaedic Surgeons lower limb outcomes assessment instruments. Reliability, validity, and sensitivity to change. J Bone Joint Surg Am. 2004 May;86(5):902-9. doi: 10.2106/00004623-200405000-00003.
PubMed 15118030Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.
PubMed 3741515
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Cross-over Study of the Efficacy of a Proprietary Cherry Juice Blend in Osteoarthritis of the Knee.
- ClinicalTrials.gov ID
- NCT00443092
- Acronym / sponsor ID
- CP100M
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, gout, pain, uric acid, tart cherry, alternative medicine, knees
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- CherryPharmIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 5 Mar 2007 (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 primary purpose of this research study is to test the ability of a proprietary cherry juice blend to be helpful in the treatment of osteoarthritis (OA) of the knee.
Detailed description
The primary objective is to determine if the proprietary tart cherry juice blend improves the pain and function in persons with knee osteoarthritis. A secondary objective is to ascertain if the blend lowers serum uric acid.
This is a prospective double blind, placebo controlled cross-over study.
The study will be performed in the Philadelphia VA Medical Center 1 South Rheumatology Clinic with patients meeting ACR criteria for Kellgren grade 2-3 knee osteoarthritis and 4-9 pain severity on a VAS. Fifty patients will be studied with each having 5 visits. Subjects will take either the proprietary cherry blend or placebo for 6 weeks and then switch. WOMAC pain and function will be the primary outcome with acetaminophen use, walking time and serum uric acid as secondary outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: proprietary cherry juice blend (food)proprietary tart cherry juice blend (8 oz., BID) |
| 2 | Placebo comparator | Other: control juice (kool aid blend)control juice (color matched kool aid blend),(8 oz., BID) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is capable of giving informed consent.
- Subject is over 18 years and less than 80 years
- Subject has mild to moderate osteoarthritis of the knee based on all of the following 3:
Key exclusion criteria (9 listed)
- Rheumatoid arthritis or other systemic inflammatory condition
- Chronic pain syndrome (fibromyalgia)
- Corticosteroid medication in last 2 months, either intra-articular or oral
- Intra-articular injections of hyaluronic acid in last 9 months
- Pregnant women (weight gain might confound degree of knee pain)
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 |
|---|---|---|
| proprietary cherry juice blend (food)2 bottles per day for 6 weeks, 1 in the morning and 1 in the evening | Other | 1 |
| control juice (kool aid blend)2 bottles per day for 6 weeks, 1 in the morning and 1 in the evening | Other | 2 |
Primary outcome
Improvement in Western Ontario McMaster Osteoarthritis Index (WOMAC) Scores to be taken at Visits 2-5.
Time frame: Visit 3 (week 6-7), Visit 5 (week 13-14)
2 secondary outcomes
Determine if there is a decrease in amount of non-prescription pain medication taken and/or improvement in score on a timed walking test (Visits 2,3,4,5).
Time frame: Visit 3 (week 6-7), Visit 5 (week 13-14)
Determine if there is a decrease in serum uric acid levels. (Visits 1,3,5)
Time frame: Visit 3 (week 6-7), Visit 5 (week 13-14)
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 3 Aug 2012.
- Background: PubMed 14776685BLAU LW. Cherry diet control for gout and arthritis. Tex Rep Biol Med. 1950;8(3):309-11. No abstract available.
- Background: PubMed 16790484Connolly DA, McHugh MP, Padilla-Zakour OI, Carlson L, Sayers SP. Efficacy of a tart cherry juice blend in preventing the symptoms of muscle damage. Br J Sports Med. 2006 Aug;40(8):679-83; discussion 683. doi: 10.1136/bjsm.2005.025429. Epub 2006 Jun 21.
- Background: PubMed 11695879Seeram NP, Momin RA, Nair MG, Bourquin LD. Cyclooxygenase inhibitory and antioxidant cyanidin glycosides in cherries and berries. Phytomedicine. 2001 Sep;8(5):362-9. doi: 10.1078/0944-7113-00053.
- Background: PubMed 17062434He YH, Zhou J, Wang YS, Xiao C, Tong Y, Tang JC, Chan AS, Lu AP. Anti-inflammatory and anti-oxidative effects of cherries on Freund's adjuvant-induced arthritis in rats. Scand J Rheumatol. 2006 Sep-Oct;35(5):356-8. doi: 10.1080/03009740600704155.
- Background: PubMed 12771324Jacob RA, Spinozzi GM, Simon VA, Kelley DS, Prior RL, Hess-Pierce B, Kader AA. Consumption of cherries lowers plasma urate in healthy women. J Nutr. 2003 Jun;133(6):1826-9. doi: 10.1093/jn/133.6.1826.
- Background: PubMed 15082468Pincus T, Koch G, Lei H, Mangal B, Sokka T, Moskowitz R, Wolfe F, Gibofsky A, Simon L, Zlotnick S, Fort JG. Patient Preference for Placebo, Acetaminophen (paracetamol) or Celecoxib Efficacy Studies (PACES): two randomised, double blind, placebo controlled, crossover clinical trials in patients with knee or hip osteoarthritis. Ann Rheum Dis. 2004 Aug;63(8):931-9. doi: 10.1136/ard.2003.020313. Epub 2004 Apr 13.
- Background: PubMed 15118030Johanson NA, Liang MH, Daltroy L, Rudicel S, Richmond J. American Academy of Orthopaedic Surgeons lower limb outcomes assessment instruments. Reliability, validity, and sensitivity to change. J Bone Joint Surg Am. 2004 May;86(5):902-9. doi: 10.2106/00004623-200405000-00003.
- Background: PubMed 3741515Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.
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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.
H. R Schumacher, M.D. principal investigator
VA Medical Center, Philadelphia & University of Pennsylvania
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 proprietary cherry juice blend (food) in people with Osteoarthritis, run by CherryPharm 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 6 inclusion and 9 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 3 Aug 2012. 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?
Improvement in Western Ontario McMaster Osteoarthritis Index (WOMAC) Scores to be taken at Visits 2-5. (time frame: Visit 3 (week 6-7), Visit 5 (week 13-14)). 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 NCT00443092, which also lists 8 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 3 Aug 2012.