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The purpose of this study is to determine whether Fumaria Parviflora L. can minimize severity of pruritus in patients with end-stage renal disease.
Uremic Pruritus is still a common complication in end-stage renal disease patients. The pathogenesis of Uremic Pruritus is unknown, therefore treatments are ineffective. According to several studies Uremic Pruritus is not an isolated skin disease. It seems to be a systemic inflammatory disease with a deranged balance of T helper cell differentiation. In this study investigators considered to evaluate effect of Fumaria Parviflora L. in uremic pruritus by a double blind placebo control clinical trial. It is hypothesized that oral Fumaria Parviflora L. may minimize uremic pruritus by decreasing serum Interferon gamma (IFN-γ) and high-sensitive C reactive protein (hs-CRP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wheat | Placebo Comparator | Placebo capsule/ 2 capsule 3 times per day |
|
| Fumaria | Active Comparator | Fumaria capsule (0.5 mg Fumaria parviflora L.) / 2 capsule 3 times per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wheat | Drug | 3 times a day each time 2 capsules before eating meal for 8 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Pruritis as measured by a visual analogue scale (VAS) | A '0' score represented absence of pruritus and a '10' represented the greatest severity of symptoms. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Interferon-gamma level | 4 months | |
| Serum IL-4 level | 4 months | |
| Serum high-sensitive C reactive protein (hs-CRP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamshid Roozbeh, MD | Shiraz University of Medical Sciences | Study Chair |
| Pouya Faridi, PhD | Shiraz University of Medical Sciences | Study Director |
| Rahimeh Akrami, PhD | Shiraz University of Medical Sciences | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21372257 | Background | Fallahzadeh MK, Roozbeh J, Geramizadeh B, Namazi MR. Interleukin-2 serum levels are elevated in patients with uremic pruritus: a novel finding with practical implications. Nephrol Dial Transplant. 2011 Oct;26(10):3338-44. doi: 10.1093/ndt/gfr053. Epub 2011 Mar 3. | |
| 16249205 | Background | Kimmel M, Alscher DM, Dunst R, Braun N, Machleidt C, Kiefer T, Stulten C, van der Kuip H, Pauli-Magnus C, Raub U, Kuhlmann U, Mettang T. The role of micro-inflammation in the pathogenesis of uraemic pruritus in haemodialysis patients. Nephrol Dial Transplant. 2006 Mar;21(3):749-55. doi: 10.1093/ndt/gfi204. Epub 2005 Oct 25. |
| Label | URL |
|---|---|
| Itching, Kidney Diseases, Kidney Failure | View source |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D005433 | Flour |
| C000713217 | Fumariae herba |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Fumaria |
| Drug |
3 times a day each time 2 capsules before eating meal for 8 weeks. |
|
| 4 months |
| 33283264 | Derived | Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2. |
| Fumaria | View source |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |