Clinical trial: Efficacy of Spearmint Tea in Relieving Osteoarthritis of the Knee (NCT01380015)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment