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Efficacy of Spearmint Tea in Relieving Osteoarthritis of the Knee

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ClinicalTrials.gov Identifier: NCT01380015
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : January 23, 2013
Sponsor:
Collaborator:
Ontario Ministry of Agriculture, Food and Rural Affairs
Information provided by (Responsible Party):
Amanda Wright, Ph.D., University of Guelph

Tracking Information
First Submitted Date  ICMJE June 21, 2011
First Posted Date  ICMJE June 27, 2011
Last Update Posted Date January 23, 2013
Study Start Date  ICMJE July 2011
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2011)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2011)
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Spearmint Tea in Relieving Osteoarthritis of the Knee
Official Title  ICMJE 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
Brief 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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Condition  ICMJE Osteoarthritis of the Knee
Intervention  ICMJE
  • Other: Commercially spearmint tea
    Commercially available, non-selectively bred spearmint tea.
  • Other: High Rosmarinic Acid Spearmint Tea
    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 Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Other: High Rosmarinic Acid Spearmint Tea
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 21, 2013)
49
Original Estimated Enrollment  ICMJE
 (submitted: June 23, 2011)
50
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01380015
Other Study ID Numbers  ICMJE 11JA040
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Amanda Wright, Ph.D., University of Guelph
Original Responsible Party Human Nutraceutical Research Unit
Current Study Sponsor  ICMJE University of Guelph
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Ontario Ministry of Agriculture, Food and Rural Affairs
Investigators  ICMJE
Principal Investigator: Amanda J Wright, Ph.D. Human Nutraceutical Research Unit
Principal Investigator: Alison M Duncan, Ph.D., R.D. Human Nutraceutical Research Unit
PRS Account University of Guelph
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP