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

This study has been completed.
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00351117
First received: July 11, 2006
Last updated: July 10, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Raynaud's Disease
Drug: St. John's Wort
Drug: Lactose
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled Trial of St.John's Wort(a Natural Health Product) in the Treatment on Raynaud's Phenomenon

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Frequency of Raynaud's Phenomenon (RP) attacks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Duration of RP attacks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Severity of RP attacks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Daily functions questionnaires (HAQ, SF-36, DASH) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Biological markers of endothelial damage (V-CAM, I-CAM, VEGF, etc.) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: March 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
St. John's wort 300mg PO TID
Drug: St. John's Wort
SJW in capsule form 300 mg PO TID
Other Name: Webber natural brand, product number 5006.
Placebo Comparator: 2
Lactose in capsule matching the St. John's wort. 300mg PO TID
Drug: Lactose
lactose in gelatin capsule that same as St. John's wort

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.

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or Females between 16 and 70 years old
  • Primary or secondary Raynaud's phenomenon, as diagnosed by a rheumatologist
  • Clinical need for treatment of Raynaud's phenomenon
  • Experiences at least 7 attacks per week
  • Willing and able to provide informed consent

Exclusion Criteria:

  • Prior allergic reaction to St. John's Wort
  • Pregnancy or possibility or pregnancy in the next 4 months
  • Women that are currently breastfeeding
  • Depression requiring treatment
  • Use of SSRIs or other antidepressants with the exception of low dose amitriptyline used for reasons other than depression
  • Use of drugs that are potentiated by St. John's Wort, such as cyclosporine, coumadin, digoxin, and theophylline. The complete list of contraindicated medications can be received from investigator
  • Clinically significant non-compliance with past therapies
  • Anticipated need for surgery (sympathectomy) in the next three months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351117

Locations
Canada, Ontario
Rheumatology Clinic, St. Joseph's Health Care
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Janet E Pope, MD, MPH Associate Professor of Medicine University of Western Ontario
  More Information

Additional Information:
Publications:

Responsible Party: Janet Pope, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00351117     History of Changes
Other Study ID Numbers: R-06-355, 250347647
Study First Received: July 11, 2006
Last Updated: July 10, 2009
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
St. John's Wort
Selective Serotonin Receptor Inhibitor
Microvasculature
Natural Health Products

Additional relevant MeSH terms:
Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014