- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01380015
Efficacy of Spearmint Tea in Relieving Osteoarthritis of the Knee
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Ontario
-
Guelph, Ontario, Canada, N1G 2W1
- University of Guelph
-
Guelph, Ontario, Canada, N1G2W1
- Human Nutraceutical Research Unit, University of Guelph
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo Control
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.
|
Commercially available, non-selectively bred 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Four months
|
Use of concomitant pain/inflammatory medications for the management of osteoarthritis symptoms
Time Frame: Four months
|
Four months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance-based measures of physical function
Time Frame: Four months
|
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).
|
Four months
|
Change in synovial fluid biomarkers of cartilage degradation
Time Frame: Four months
|
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).
|
Four months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Amanda J Wright, Ph.D., Human Nutraceutical Research Unit
- Principal Investigator: Alison M Duncan, Ph.D., R.D., Human Nutraceutical Research Unit
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Osteoarthritis, Knee
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Platelet Aggregation Inhibitors
- Protease Inhibitors
- Protective Agents
- Serine Proteinase Inhibitors
- Antioxidants
- Rosmarinic acid
Other Study ID Numbers
- 11JA040
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoarthritis of the Knee
-
Taiwan Liposome CompanyCompletedOSTEOARTHRITIS OF THE KNEETaiwan, United States
-
University Hospital, GhentCompletedOsteoarthritis of the Knee JointBelgium
-
Bone Therapeutics S.ANordic Bioscience A/SCompletedSymptomatic Osteoarthritis of the KneeDenmark, Belgium, United Kingdom, Czechia, Hong Kong, Moldova, Republic of, Poland
-
Rush University Medical CenterWithdrawnSymptomatic Osteoarthritis of the Knee
-
Region SkaneRecruitingOsteoarthritis of the Knee or HipSweden
-
UMC UtrechtCompletedMedial Compartment Osteoarthritis of the KneeNetherlands
-
Massachusetts General HospitalGöteborg University; Seoul National University Hospital; Ulsan University Hospital and other collaboratorsUnknownOsteoarthritis of the Knee | Traumatic Arthritis of the KneeUnited States
-
Ampio Pharmaceuticals. Inc.TerminatedSevere Osteoarthritis of the KneeUnited States
-
Ampio Pharmaceuticals. Inc.TerminatedSevere Osteoarthritis of the KneeUnited States
-
Hospital General de Jerez de la FronteraZiekenhuis Oost-LimburgCompletedPainful Osteoarthritis of the KneeSpain
Clinical Trials on Commercially spearmint tea
-
Kemin Foods LCMusclePharm Sports Science InstituteCompletedSleep | Mood | Cognitive PerformanceUnited States
-
Providence Health & ServicesCompletedMetastatic Sarcoma | Metastatic Carcinoma | Metastatic LymphomaUnited States
-
University of ArizonaUnited States Department of DefenseCompletedLung Cancer Prevention
-
Colorado State UniversityInstitute of Cannabis Research (ICR)--Colorado State University, PuebloRecruitingAlcohol Use Disorder | Cannabis UseUnited States
-
MedtronicNeuroRecruitingPain, Chronic | Pain, IntractableUnited States
-
University of the PacificCompletedCardiovascular DiseasesUnited States
-
University of Missouri-ColumbiaCompletedGlucose | Blood Sugar; High | Glucose Metabolism Disorders (Including Diabetes Mellitus)United States
-
Massachusetts General HospitalHarvard School of Public Health (HSPH)Completed
-
Cardiff UniversityCompletedCommon Cold/FluUnited Kingdom
-
Universitair Ziekenhuis BrusselCompletedInfertility, FemaleBelgium