Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00351117
Study type Interventional
Source Lawson Health Research Institute
Contact
Status Completed
Phase Phase 3
Start date March 2007
Completion date August 2008

See also
  Status Clinical Trial Phase
Completed NCT00000530 - Raynaud's Treatment Study (RTS) Phase 3
Completed NCT00048763 - Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud’s Phenomenon Phase 4
Completed NCT00048776 - Safety and Efficacy of Pletal (Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud’s Phenomenon Phase 4
Enrolling by invitation NCT02615964 - Nova Cold Hands Raynaud's Disorder, a Disease Which Results in Decreased Blood Flow to the Hands and Feet. N/A
Completed NCT01309802 - A Two-Part Study of BOTOX® Therapy for Ischemic Digits Phase 2
Completed NCT00480753 - Dose Response Study of a Topical Formulation of Nitroglycerin for the Treatment of Raynaud's Phenomenon Phase 2
Completed NCT02396238 - Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR) N/A
Completed NCT00528242 - Safety, Tolerability, and Pharmacodynamic Profile of Oral 2101 in Secondary Raynaud's Disease Phase 2
Completed NCT00378521 - Dose Response Study of a Topical Gel for the Treatment of Raynaud's Phenomenon Phase 2
Completed NCT02683408 - Diosmiplex (Vasculera®) in Primary and Secondary Raynaud's Phenomenon N/A
Active, not recruiting NCT00577304 - A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon Phase 3
Completed NCT00419419 - Phase III Study of a Topical Gel Formulation for Treatment and Prevention of Raynaud's Phenomenon Phase 3
Completed NCT00266669 - Phase III Study of Topical Gel for Treatment and Prevention of Raynaud's Phenomenon Phase 3
Completed NCT01090492 - PF-00489791 For The Treatment Of Raynaud's Phase 2