Evaluating the Effect of Senna in Uremic Pruritus

Not Applicable

Completed

• Conditions: End Stage Renal Disease; Pruritus
• Interventions: Drug: Placebo; Drug: Senna

• Registration Number: NCT02008864
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2012-09
• Study First Submitted: 2013-12-01
• Study First Submitted QC: 2013-12-06
• Study First Posted: 2013-12-11
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Hemodialysis patients
• Suffering from pruritus for at least 6 weeks
• Have not responded to other drugs

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Exclusion Criteria

• Dermatological disease
• Liver disease
• Metabolic disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Wheat
Senna	Senna	Senna

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Serum IL-2 level	3 months