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| ID | Type | Description | Link |
|---|---|---|---|
| 250347647 |
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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.
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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | St. John's wort 300mg PO TID |
|
| 2 | Placebo Comparator | Lactose in capsule matching the St. John's wort. 300mg PO TID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| St. John's Wort | Drug | SJW in capsule form 300 mg PO TID |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Raynaud's Phenomenon (RP) attacks | 6 weeks | |
| Duration of RP attacks | 6 weeks | |
| Severity of RP attacks | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Daily functions questionnaires (HAQ, SF-36, DASH) | 6 weeks | |
| Biological markers of endothelial damage (V-CAM, I-CAM, VEGF, etc.) | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janet E Pope, MD, MPH | Associate Professor of Medicine University of Western Ontario | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Clinic, St. Joseph's Health Care | London | Ontario | N6A 4V2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10759336 | Background | Schrader E. Equivalence of St John's wort extract (Ze 117) and fluoxetine: a randomized, controlled study in mild-moderate depression. Int Clin Psychopharmacol. 2000 Mar;15(2):61-8. doi: 10.1097/00004850-200015020-00001. | |
| 11561116 | Background | Coleiro B, Marshall SE, Denton CP, Howell K, Blann A, Welsh KI, Black CM. Treatment of Raynaud's phenomenon with the selective serotonin reuptake inhibitor fluoxetine. Rheumatology (Oxford). 2001 Sep;40(9):1038-43. doi: 10.1093/rheumatology/40.9.1038. |
| Label | URL |
|---|---|
| American website of institute of arthritis: general medical information on Raynaud's Disease | View source |
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| ID | Term |
|---|---|
| D011928 | Raynaud Disease |
| ID | Term |
|---|---|
| D000090122 | Livedoid Vasculopathy |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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Not provided
| ID | Term |
|---|---|
| C422326 | Hypericum extract LI 160 |
| D007785 | Lactose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Lactose | Drug | lactose in gelatin capsule that same as St. John's wort |
|
| 12967424 | Background | Pope J. Raynaud's phenomenon (primary). Clin Evid. 2003 Jun;(9):1339-48. No abstract available. |
| 8434812 | Background | Bolte MA, Avery D. Case of fluoxetine-induced remission of Raynaud's phenomenon--a case report. Angiology. 1993 Feb;44(2):161-3. doi: 10.1177/000331979304400213. No abstract available. |
| 10823363 | Background | Brenner R, Azbel V, Madhusoodanan S, Pawlowska M. Comparison of an extract of hypericum (LI 160) and sertraline in the treatment of depression: a double-blind, randomized pilot study. Clin Ther. 2000 Apr;22(4):411-9. doi: 10.1016/S0149-2918(00)89010-4. |
| 14705233 | Background | Pope JE, Prashker M, Anderson J. The efficacy and cost effectiveness of N of 1 studies with diclofenac compared to standard treatment with nonsteroidal antiinflammatory drugs in osteoarthritis. J Rheumatol. 2004 Jan;31(1):140-9. |
| 7752794 | Background | Jaffe IA. Serotonin reuptake inhibitors in Raynaud's phenomenon. Lancet. 1995 May 27;345(8961):1378. doi: 10.1016/s0140-6736(95)92582-1. No abstract available. |
| 15554758 | Background | Knuppel L, Linde K. Adverse effects of St. John's Wort: a systematic review. J Clin Psychiatry. 2004 Nov;65(11):1470-9. doi: 10.4088/jcp.v65n1105. |
| 12153829 | Background | Lecrubier Y, Clerc G, Didi R, Kieser M. Efficacy of St. John's wort extract WS 5570 in major depression: a double-blind, placebo-controlled trial. Am J Psychiatry. 2002 Aug;159(8):1361-6. doi: 10.1176/appi.ajp.159.8.1361. |
| Canadian complementary and alternative medicine research group: contains details on how to conduct a natural product trials and has a lot of resources. | View source |
| A database that is linked to MedLine and does searches for herbal medicine only. | View source |
| Health Canada Natural Health product site: information on regulation and legislature | View source |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000073893 |
| Sugars |