End Stage Renal Disease, Pruritus
Conditions
Keywords
End stage renal diseases, Hemodialysis, Uremic pruritus, Iranian traditional medicine, Cassia angustifolia
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.
Interventions
DRUGSenna
(7.5 mg of sennosoides A and B) Senna tablet/ 2 times per day
DRUGPlacebo
Placebo tablet/ 2 times per day
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Serum IL-2 level | 3 months |
Outcome results
None listed