Evaluating the Effect of Senna in Uremic Pruritus
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Sponsorii
Shiraz University of Medical Sciences
STUDIU CLINIC: NCT02008864
BioSeek: nct02008864
Cuvinte cheie
Abstract
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.
Datele
Ultima verificare: | 02/28/2015 |
Primul depus: | 11/30/2013 |
Inscriere estimată trimisă: | 12/05/2013 |
Prima postare: | 12/10/2013 |
Ultima actualizare trimisă: | 03/29/2015 |
Ultima actualizare postată: | 03/31/2015 |
Data actuală de începere a studiului: | 07/31/2011 |
Data estimată de finalizare primară: | 08/31/2012 |
Stare sau boală
End Stage Renal Disease
Pruritus
Intervenție / tratament
Drug: Senna
Drug: Placebo
Fază
-
Grupuri de brațe
Braţ | Intervenție / tratament |
---|---|
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 |
Criterii de eligibilitate
Vârste eligibile pentru studiu | 18 Years La 18 Years |
Sexe eligibile pentru studiu | All |
Acceptă voluntari sănătoși | da |
Criterii | 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 |
Rezultat
Măsuri de rezultate primare
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.
Măsuri de rezultate secundare
1. Serum IL-2 level [3 months]