St. John's Wort in the Treatment of Raynaud's Phenomenon
Condition: Raynaud's Disease
MeSH terms: Raynaud Disease
Study type: Interventional
Phase: Phase 3

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 description: 
      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 phase.

      Patients participation will span 8-10 weeks. The first two weeks are a baseline measurement
      for the status of RP using the journals, questionnaires, and serum tests. The treatment
      period will last 6 weeks in which the subject will be taking the capsules that they have been
      assigned and will be evaluated for changes or side-effects every two weeks. At the last visit
      the questionnaires and serum test will be repeated.

      Other results which may arise from the trial are:

        -  The safety of SJW in rheumatology patients, by monitoring side-effects

        -  The attitude of rheumatology patients in using Natural Health Products, by a
           questionnaire

        -  Elucidating parts of the RP mechanism, by measuring bio-markers

        -  Differences between primary and secondary RP, by stratified randomization

      The results will be analyzed for all three primary outcome measures as a difference of
      between baseline and treatment. These differences will be compared between treatment and
      placebo and each will be stratified for primary vs. secondary and possibly other demographic
      data.

      This trial, if positive, will offer another treatment to RP patients. This option will
      possibly have less side-effects and be better accepted because it is a Natural Product.
    

Intervention name(s): St. John's Wort; Lactose
Intervention type(s): Drug; Drug
Intervention description(s): SJW in capsule form 300 mg PO TID; lactose in gelatin capsule that same as St. John's wort
Other intervention name(s): Webber natural brand, product number 5006.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: St. John's Wort; Selective Serotonin Receptor Inhibitor; Microvasculature; Natural Health Products