Clinical Trial: St. John's Wort in the Treatment of Raynaud's Phenomenon

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Placebo-controlled Trial of St.John's Wort(a Natural Health Product) in the Treatment on Raynaud's Phenomenon

Brief Summary:

This trial will test the efficacy of St. John's Wort (SJW) as a supplement, in the treatment of Raynaud's phenomenon (RP). The investigators are hypothesizing that taking SJW 300mg, 3 times a day will decrease the frequency, duration, and severity of RP attacks when compared to placebo.

Patients with RP will answer questionnaires and self-evaluate their symptoms of RP as a baseline. Then they will be assigned to either a treatment (will receive SJW capsules) or placebo (will receive non-therapeutic capsules) group. They will be required to take their capsules, self-evaluate their progress and be evaluated every two weeks in a clinic. The treatment phase will last six weeks.

This trial will be conducted in a way to mimic the normal usage of natural products. Patients will not be required to stop any current treatment for RP.


Detailed Summary:

Raynaud's Phenomenon (RP) is a common vasospastic problem of digital artery vessels causing pain and ischemic fingers (the fingers turn white and then blue and or red). It is considered primary when it is not associated with other conditions. Raynaud's symptoms that are associated with pathological underlying cause especially connective tissue diseases are defined as secondary Raynaud's and are usually more severe than primary symptoms. Selective Serotonin receptor inhibitors (SSRIs) have shown to be effective in decreasing the symptoms of RP.

St. John's Wort (SJW) is an natural product that is presently approved by Health Canada for treatment of depression. It is believed that SJW would have mechanism of action very similar to SSRIs.

This clinical trial will measure the efficiency of SJW in decreasing the frequency, duration and severity of RP attacks. SJW will be test as a supplement to other treatments already in place. 76 patients (38 with primary Raynaud's and half with secondary Raynaud's) will be recruited from the Rheumatology clinic of St. Joseph's Health Care in London, Ontario. The recruitment period will span 18 months. As they enter the trial, subjects will be assigned to a treatment or a placebo group according to a pre-set randomization schedule. This assignment will be stratified for primary or secondary Raynaud's and double-blinded (patient and investigator).

The primary outcome measure (frequency, duration and severity) will be assessed by the patient on a daily basis using a journal provided by the investigator. Secondary outcome measures will include functions questionnaires (HAQ, SF-36, DASH) and biological markers of endothelial damage (V-CAM, I-CAM, VEGF, von Willebrand factor), will be conducted as a baseline and at the conclusion of the treatment ph
Sponsor: Lawson Health Research Institute

Current Primary Outcome:

  • Frequency of Raynaud's Phenomenon (RP) attacks [ Time Frame: 6 weeks ]
  • Duration of RP attacks [ Time Frame: 6 weeks ]
  • Severity of RP attacks [ Time Frame: 6 weeks ]


Original Primary Outcome:

  • Frequency of Raynaud's Phenomenon (RP) attacks
  • Duration of RP attacks
  • Severity of RP attacks


Current Secondary Outcome:

  • Daily functions questionnaires (HAQ, SF-36, DASH) [ Time Frame: 6 weeks ]
  • Biological markers of endothelial damage (V-CAM, I-CAM, VEGF, etc.) [ Time Frame: 6 weeks ]


Original Secondary Outcome:

  • Daily functions questionnaires (HAQ, SF-36, DASH)
  • Biological markers of endothelial damage (V-CAM, I-CAM, VEGF, etc.)


Information By: Lawson Health Research Institute

Dates:
Date Received: July 11, 2006
Date Started: March 2007
Date Completion:
Last Updated: July 10, 2009
Last Verified: July 2009