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

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute

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