Evaluating the Effect of Senna in Uremic Pruritus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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End Stage Renal Disease Pruritus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Wheat

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet/ 2 times per day

Senna

Group Type ACTIVE_COMPARATOR

Senna

Intervention Type DRUG

(7.5 mg of sennosoides A and B) Senna tablet/ 2 times per day

Interventions

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Senna

(7.5 mg of sennosoides A and B) Senna tablet/ 2 times per day

Intervention Type DRUG

Placebo

Placebo tablet/ 2 times per day

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Pouya Faridi

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR