Efficacy of Spearmint Tea in Relieving Osteoarthritis of the Knee
Ključne riječi
Sažetak
Opis
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).
Datumi
| Posljednja provjera: | 12/31/2012 |
| Prvo podneseno: | 06/20/2011 |
| Predviđena prijava predata: | 06/22/2011 |
| Prvo objavljeno: | 06/26/2011 |
| Zadnje ažuriranje poslato: | 01/20/2013 |
| Posljednje ažuriranje objavljeno: | 01/22/2013 |
| Stvarni datum početka studija: | 06/30/2011 |
| Procijenjeni datum primarnog završetka: | 10/31/2012 |
| Predviđeni datum završetka studije: | 11/30/2012 |
Stanje ili bolest
Intervencija / liječenje
Other: Placebo Control
Other: Experimental
Faza
Grupe ruku
| Arm | Intervencija / liječenje |
|---|---|
| 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. | Other: Placebo Control 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. | Other: Experimental 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. |
Kriteriji prihvatljivosti
| Uzrast podoban za studiranje | 18 Years To 18 Years |
| Polovi podobni za studiranje | All |
| Prihvaća zdrave volontere | Da |
| Kriterijumi | 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. |
Ishod
Primarne mjere ishoda
1. Self-reported ratings of pain and physical function [Four months]
2. Use of concomitant pain/inflammatory medications for the management of osteoarthritis symptoms [Four months]
Sekundarne mjere ishoda
1. Performance-based measures of physical function [Four months]
2. Change in synovial fluid biomarkers of cartilage degradation [Four months]
