Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00351117
Other study ID # R-06-355
Secondary ID 250347647
Status Completed
Phase Phase 3
First received July 11, 2006
Last updated July 10, 2009
Start date March 2007
Est. completion date August 2008

Study information

Verified date July 2009
Source Lawson Health Research Institute
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

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.


Description:

Read more »
Read more »

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


Intervention

Drug:
St. John's Wort
SJW in capsule form 300 mg PO TID
Lactose
lactose in gelatin capsule that same as St. John's wort

Locations

Country Name City State
Canada Rheumatology Clinic, St. Joseph's Health Care London Ontario

Sponsors (1)

Lead Sponsor Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (9)

See more »

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of Raynaud's Phenomenon (RP) attacks 6 weeks No
Primary Duration of RP attacks 6 weeks No
Primary Severity of RP attacks 6 weeks No
Secondary Daily functions questionnaires (HAQ, SF-36, DASH) 6 weeks No
Secondary Biological markers of endothelial damage (V-CAM, I-CAM, VEGF, etc.) 6 weeks No
See also
  Status Clinical Trial Phase
Completed NCT00000530 - Raynaud's Treatment Study (RTS) Phase 3
Completed NCT00048776 - Safety and Efficacy of Pletal (Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud’s Phenomenon Phase 4
Completed NCT00048763 - 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