Evaluating the Effect of Senna in Uremic Pruritus
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StatusZavršeno
Sponzori
Shiraz University of Medical Sciences
KLINIČKIM ISPITIVANJIMA: NCT02008864
BioSeek: nct02008864
Ključne riječi
Sažetak
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.
Datumi
Posljednja provjera: | 02/28/2015 |
Prvo podneseno: | 11/30/2013 |
Predviđena prijava predata: | 12/05/2013 |
Prvo objavljeno: | 12/10/2013 |
Zadnje ažuriranje poslato: | 03/29/2015 |
Posljednje ažuriranje objavljeno: | 03/31/2015 |
Stvarni datum početka studija: | 07/31/2011 |
Procijenjeni datum primarnog završetka: | 08/31/2012 |
Stanje ili bolest
End Stage Renal Disease
Pruritus
Intervencija / liječenje
Drug: Senna
Drug: Placebo
Faza
-
Grupe ruku
Arm | Intervencija / liječenje |
---|---|
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 |
Kriteriji prihvatljivosti
Uzrast podoban za studiranje | 18 Years To 18 Years |
Polovi podobni za studiranje | All |
Prihvaća zdrave volontere | Da |
Kriterijumi | 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 |
Ishod
Primarne mjere ishoda
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.
Sekundarne mjere ishoda
1. Serum IL-2 level [3 months]