Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351117
Status:
COMPLETED
Last Update Posted:
2009-07-14
First Post:
2006-07-11
Brief Title:
St Johns Wort in the Treatment of Raynauds Phenomenon
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
A Randomized Placebo-controlled Trial of StJohns Worta Natural Health Product in the Treatment on Raynauds Phenomenon
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial will test the efficacy of St Johns Wort SJW as a supplement in the treatment of Raynauds 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
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
Detailed Description:
Raynauds 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 Raynauds symptoms that are associated with pathological underlying cause especially connective tissue diseases are defined as secondary Raynauds 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 Johns 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 Raynauds and half with secondary Raynauds will be recruited from the Rheumatology clinic of St Josephs 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 Raynauds 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
St Johns 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 Raynauds and half with secondary Raynauds will be recruited from the Rheumatology clinic of St Josephs 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 Raynauds 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 250347647 | None | None | None |