Osteoarthritis of the KneePhase 4NCT01380015
Efficacy of Spearmint Tea in Relieving Osteoarthritis of the Knee
A Phase 4 study testing Commercially spearmint tea and High Rosmarinic Acid Spearmint Tea in people with Osteoarthritis of the Knee, run by University of Guelph at 2 sites in Canada.
Trial summary
The purpose of this study is to investigate the benefits of daily consumption of a high rosmarinic acid spearmint tea, developed by the University of Guelph, on measures of pain, physical function and disease activity in osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Commercially spearmint tea and High Rosmarinic Acid Spearmint Tea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2011to Dec 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is at least 18 years or older
- Have been diagnosed by a health care professional with osteoarthritis of the knee
- Demonstrates a WOMAC pain score greater then 125 at time of study screening
Who cannot join
- Has any other systemic or rheumatic arthritis
- Has completed or is planning to undergo knee replacement surgery
- Has had a chemical, radiologic, or surgical synovectomy in any large joint within the previous 3 months
- Has any concomitant inflammatory processes such as infectious or rheumatic disease
- Has any gastrointestinal ulcers
- Has any clinically significant, uncontrolled cardiovascular, hepatic, renal, or any other medical condition that may interfere with the study
Show all 12Show fewer
- Has any serious medication conditions such as recent (within the previous 6 months) heart attack, stroke, cancer and/or diabetes
- Has a recent history (within the previous 6 months) of a clinically significant psychiatric disorder other than mild depression
- Has a known allergy or hypersensitivity to mint or any other food allergies
- Smokes, drinks alcohol (>14 drinks per week) or participates in recreational drug use
- Has participated in a clinical trial involving an investigational or marketed drug within the previous 6 months
- Women who are pregnant or plan to become pregnant during the study period, women who have recently (within the previous 6 months) given birth, women who are currently lactating or have only recently (within the previous 6 months) stopped lactating.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Guelph
Guelph, Ontario, N1G 2W1
Human Nutraceutical Research Unit, University of Guelph
Guelph, Ontario, N1G2W1
About this study
Official title: Human Clinical Trial to Investigate the Effects of High Rosmarinic Acid Spearmint Tea on Markers of Pain, Physical Function and Disease Activity in Osteoarthritis of the Knee
The purpose of this study is to investigate the benefits of daily consumption of a high rosmarinic acid spearmint tea, developed by the University of Guelph, on measures of pain, physical function and disease activity in osteoarthritis of the knee.
The investigators hypothesize that a spearmint tea high in rosmarinic acid is efficacious in mitigating the symptoms of osteoarthritis of the knee through its actions in reducing cartilage degradation, oxidative stress and inflammation.
Read the detailed description
Healthy adults with a clinical diagnosis of osteoarthritis of the knee will be recruited and will undergo a brief phone screening interview, followed by a detailed in-person screening process, to determine study eligibility.
Eligible participants will be matched according to sex, baseline pain according to the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score, and duration of osteoarthritis. Participants will then be randomly assigned to receive either the investigative high rosmarinic acid spearmint tea or a comparable placebo mint tea.
During the 4-month treatment period, participants will consume two cups (300 mL in the morning and 300 mL in the evening) of either the high rosmarinic acid spearmint tea (approximately 300 mg rosmarinic acid per day) or the commercial spearmint tea (approximately 20 mg of rosmarinic acid per day) daily.
Data collection will occur at baseline (week 0), mid-treatment (week 8), post-treatment (week 16), and follow-up (week 20). Outcome measures include WOMAC and SF-36 scores, physical function (6-minute walk, stair climb task), inflammatory markers (serum C-reactive protein), and self-reported changes in pain medication use. In a sub-set of consenting participants deemed eligible by the study physician, a synovial fluid sample will be drawn from the knee for the analyses of cartilage degradation biomarkers (GAG, COMP, PGE2, NO) at baseline (week 0) and post-treatment (week 16).
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Commercially spearmint tea, High Rosmarinic Acid Spearmint Tea
- Keywords
- osteoarthritis, spearmint, rosmarinic acid
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercially spearmint teaOther
Commercially available, non-selectively bred spearmint tea.
High Rosmarinic Acid Spearmint TeaOther
The investigational product will be a high rosmarinic acid spearmint tea (700B) developed by the Department of Plant Agriculture, University of Guelph. Clone 700B has been selectively bred to contain a rosmarinic acid content 15-20 times greater than that of typical mint.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control | Placebo comparator | Participants will consume two cups of commercial spearmint tea per day (300 mL in the morning and 300 mL in the evening, providing a total of approximately 20 mg of rosmarinic acid per day) for a total of 4 months. Receives: Other: Commercially spearmint tea |
| Experimental | Experimental | Participants will consume two cups of a high rosmarinic acid spearmint tea per day (300 mL in the morning and 300 mL in the evening, providing a total of approximately 300 mg of rosmarinic acid per day) for a total of 4 months. Receives: Other: High Rosmarinic Acid Spearmint Tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported ratings of pain and physical function
Data collection of self-reported ratings of pain and physical function (WOMAC), self-reported ratings of overall physical and mental health (SF-36), and self-reported changes in the use of concomitant pain and inflammation medications (study diary) will occur at baseline (week 0), mid-treatment (week 8), post-treatment (week 16), and follow-up (week 20).
Measured: Four months
Use of concomitant pain/inflammatory medications for the management of osteoarthritis symptoms
Measured: Four months
Secondary outcomes (2)
Performance-based measures of physical function
Data for performance-based assessment of physical function (6-minute walk, stair climb task) will be collected at baseline (week 0), mid-treatment (week 8), post-treatment (week 16), and follow-up (week 20).
Measured: Four months
Change in synovial fluid biomarkers of cartilage degradation
In a sub-set of participants, a synovial fluid sample will be drawn (i.e. arthocentesis) for the analyses of cartilage degradation biomarkers (GAG, COMP, PGE2, NO) at baseline (week 0) and post-treatment (week 16).
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the KneeStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Agriculture, Food and Rural Affairs
- Responsible party
- Principal investigator, Amanda Wright, Ph.D., University of Guelph
- Investigators
- Amanda J Wright, Ph.D., Principal investigator, Human Nutraceutical Research UnitAlison M Duncan, Ph.D., R.D., Principal investigator, Human Nutraceutical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380015
- Sponsor's protocol ID
- 11JA040
- Status last verified
- Jan 2013
- First submitted
- 21 Jun 2011
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Connelly AE, Tucker AJ, Tulk H, Catapang M, Chapman L, Sheikh N, Yurchenko S, Fletcher R, Kott LS, Duncan AM, Wright AJ. High-rosmarinic acid spearmint tea in the management of knee osteoarthritis symptoms. J Med Food. 2014 Dec;17(12):1361-7. doi: 10.1089/jmf.2013.0189.
PubMed 25058311
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Clinical Trial to Investigate the Effects of High Rosmarinic Acid Spearmint Tea on Markers of Pain, Physical Function and Disease Activity in Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT01380015
- Acronym / sponsor ID
- 11JA040
- Conditions
- Osteoarthritis of the Knee
- Keywords
- osteoarthritis, spearmint, rosmarinic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Collaborators
- Ontario Ministry of Agriculture, Food and Rural Affairs
- Study start
- Jul 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Jun 2011 (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 investigate the benefits of daily consumption of a high rosmarinic acid spearmint tea, developed by the University of Guelph, on measures of pain, physical function and disease activity in osteoarthritis of the knee.
The investigators hypothesize that a spearmint tea high in rosmarinic acid is efficacious in mitigating the symptoms of osteoarthritis of the knee through its actions in reducing cartilage degradation, oxidative stress and inflammation.
Detailed description
Healthy adults with a clinical diagnosis of osteoarthritis of the knee will be recruited and will undergo a brief phone screening interview, followed by a detailed in-person screening process, to determine study eligibility.
Eligible participants will be matched according to sex, baseline pain according to the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score, and duration of osteoarthritis. Participants will then be randomly assigned to receive either the investigative high rosmarinic acid spearmint tea or a comparable placebo mint tea.
During the 4-month treatment period, participants will consume two cups (300 mL in the morning and 300 mL in the evening) of either the high rosmarinic acid spearmint tea (approximately 300 mg rosmarinic acid per day) or the commercial spearmint tea (approximately 20 mg of rosmarinic acid per day) daily.
Data collection will occur at baseline (week 0), mid-treatment (week 8), post-treatment (week 16), and follow-up (week 20). Outcome measures include WOMAC and SF-36 scores, physical function (6-minute walk, stair climb task), inflammatory markers (serum C-reactive protein), and self-reported changes in pain medication use. In a sub-set of consenting participants deemed eligible by the study physician, a synovial fluid sample will be drawn from the knee for the analyses of cartilage degradation biomarkers (GAG, COMP, PGE2, NO) at baseline (week 0) and post-treatment (week 16).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Control | Placebo comparator | Other: Commercially spearmint teaParticipants will consume two cups of commercial spearmint tea per day (300 mL in the morning and 300 mL in the evening, providing a total of approximately 20 mg of rosmarinic acid per day) for a total of 4 months. |
| Experimental | Experimental | Other: High Rosmarinic Acid Spearmint TeaParticipants will consume two cups of a high rosmarinic acid spearmint tea per day (300 mL in the morning and 300 mL in the evening, providing a total of approximately 300 mg of rosmarinic acid per day) for a total of 4 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Is at least 18 years or older
- Have been diagnosed by a health care professional with osteoarthritis of the knee
- Demonstrates a WOMAC pain score greater then 125 at time of study screening
Key exclusion criteria (12 listed)
- Has any other systemic or rheumatic arthritis
- Has completed or is planning to undergo knee replacement surgery
- Has had a chemical, radiologic, or surgical synovectomy in any large joint within the previous 3 months
- Has any concomitant inflammatory processes such as infectious or rheumatic disease
- Has any gastrointestinal ulcers
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 |
|---|---|---|
| Commercially spearmint teaCommercially available, non-selectively bred spearmint tea. | Other | Placebo Control |
| High Rosmarinic Acid Spearmint TeaThe investigational product will be a high rosmarinic acid spearmint tea (700B) developed by the Department of Plant Agriculture, University of Guelph. Clone 700B has been selectively bred to contain a rosmarinic acid content 15-20 times greater than that of typical mint. | Other | Experimental |
Primary outcome
Self-reported ratings of pain and physical function
Time frame: Four months
Data collection of self-reported ratings of pain and physical function (WOMAC), self-reported ratings of overall physical and mental health (SF-36), and self-reported changes in the use of concomitant pain and inflammation medications (study diary) will occur at baseline (week 0), mid-treatment (week 8), post-treatment (week 16), and follow-up (week 20).
Use of concomitant pain/inflammatory medications for the management of osteoarthritis symptoms
Time frame: Four months
2 secondary outcomes
Performance-based measures of physical function
Time frame: Four months
Change in synovial fluid biomarkers of cartilage degradation
Time frame: Four 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 23 Jan 2013.
- Derived from this study: PubMed 25058311Connelly AE, Tucker AJ, Tulk H, Catapang M, Chapman L, Sheikh N, Yurchenko S, Fletcher R, Kott LS, Duncan AM, Wright AJ. High-rosmarinic acid spearmint tea in the management of knee osteoarthritis symptoms. J Med Food. 2014 Dec;17(12):1361-7. doi: 10.1089/jmf.2013.0189.
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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.
Amanda J Wright, Ph.D. principal investigator
Human Nutraceutical Research Unit
Alison M Duncan, Ph.D., R.D. principal investigator
Human Nutraceutical Research Unit
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Commercially spearmint tea and High Rosmarinic Acid Spearmint Tea in people with Osteoarthritis of the Knee, run by University of Guelph at 2 sites in Canada.
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 3 inclusion and 12 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 23 Jan 2013. 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 Canada. 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?
Self-reported ratings of pain and physical function (time frame: Four months). The study lists 2 primary outcomes in all. 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 NCT01380015, which also lists 1 linked publication.
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 23 Jan 2013.