Evaluating the Effect of Senna in Uremic Pruritus
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Sponsorlar
Shiraz University of Medical Sciences
KLINIK ÇALIŞMA: NCT02008864
BioSeek: nct02008864
Anahtar kelimeler
Öz
Uremic pruritus remains one of the most frustrating and potentially disabling symptoms in patients with end stage renal disease. It affect up to 90 percent of patients with end stage renal disease. Several hypotheses have been postulated for the possible underlying etiology, but none is conclusive. Aside from kidney transplantation, which is only definitive treatment, therapeutic approaches have largely been empirical, and no firm evident-base treatments are available. The main goal of therapy remains to minimize severity of pruritus. In Iranian traditional medicine Cassia senna L. is used for healing uremic pruritus . In this study investigators considered to evaluate effect of Cassia senna L. in uremic pruritus by a double blind placebo control clinical trial. It is hypothesized that oral Cassia senna L. may attenuate uremic pruritus by decreasing serum IL-2, IFN-γ and TNF-α.
Tarih
Son Doğrulandı: | 02/28/2015 |
İlk Gönderilen: | 11/30/2013 |
Tahmini Kayıt Gönderildi: | 12/05/2013 |
İlk Gönderilen: | 12/10/2013 |
Son Güncelleme Gönderildi: | 03/29/2015 |
Son Güncelleme Gönderildi: | 03/31/2015 |
Fiili Çalışma Başlangıç Tarihi: | 07/31/2011 |
Tahmini Birincil Tamamlanma Tarihi: | 08/31/2012 |
Durum veya hastalık
End Stage Renal Disease
Pruritus
Müdahale / tedavi
Drug: Senna
Drug: Placebo
Evre
-
Kol Grupları
Kol | Müdahale / tedavi |
---|---|
Placebo Comparator: Placebo Wheat | Drug: Placebo Placebo tablet/ 2 times per day |
Active Comparator: Senna Senna | Drug: Senna (7.5 mg of sennosoides A and B) Senna tablet/ 2 times per day |
Uygunluk kriterleri
Çalışmaya Uygun Yaşlar | 18 Years İçin 18 Years |
Çalışmaya Uygun Cinsiyetler | All |
Sağlıklı Gönüllüleri Kabul Ediyor | Evet |
Kriterler | Inclusion Criteria: - Hemodialysis patients - Suffering from pruritus for at least 6 weeks - Have not responded to other drugs Exclusion Criteria: - Dermatological disease - Liver disease - Metabolic disease |
Sonuç
Birincil Sonuç Ölçütleri
1. Severity of Pruritis, as measured by a visual analogue scale [3 months]
A '0' score represented absence of pruritus and a '10' represented the greatest severity of symptoms.
İkincil Sonuç Ölçütleri
1. Serum IL-2 level [3 months]