Evaluating the Effect of Senna in Uremic Pruritus
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StatusAfsluttet
Sponsorer
Shiraz University of Medical Sciences
KLINISK FORSØG: NCT02008864
BioSeek: nct02008864
Nøgleord
Abstrakt
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.
Datoer
Sidst bekræftet: | 02/28/2015 |
Først indsendt: | 11/30/2013 |
Anslået tilmelding indsendt: | 12/05/2013 |
Først indsendt: | 12/10/2013 |
Sidste opdatering indsendt: | 03/29/2015 |
Sidste opdatering indsendt: | 03/31/2015 |
Faktisk startdato for undersøgelsen: | 07/31/2011 |
Anslået primær afslutningsdato: | 08/31/2012 |
Tilstand eller sygdom
End Stage Renal Disease
Pruritus
Intervention / behandling
Drug: Senna
Drug: Placebo
Fase
-
Armgrupper
Arm | Intervention / behandling |
---|---|
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 |
Kriterier for støtteberettigelse
Alder berettiget til undersøgelse | 18 Years Til 18 Years |
Køn, der er berettiget til undersøgelse | All |
Accepterer sunde frivillige | Ja |
Kriterier | 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 |
Resultat
Primære resultatforanstaltninger
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.
Sekundære resultatforanstaltninger
1. Serum IL-2 level [3 months]