Evaluating the Effect of Senna in Uremic Pruritus

NCT02008864 — Not applicable, Completed, 60 participants, Shiraz University of Medical Sciences

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Phase II Study of the Effect of Senna Alexandrina Mill. on Uremic Pruritus and Serum IL-2, INF-δ and TNF-α Levels of Hemodialysed Patients

Registry	NCT02008864
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	60 (Actual)
Sponsor	Shiraz University of Medical Sciences (Other)
Conditions	End Stage Renal Disease, Pruritus
Interventions	Senna, Placebo (Drug)
Dates	start 2011-08-01, primary completion 2012-09-01, first posted 2013-12-11, last updated 2015-04-01

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Placebo	Placebo comparator	Drug: Placebo	Wheat
Senna	Active comparator	Drug: Senna	Senna

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

+Outcome measures

Primary outcomes

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 outcomes

Serum IL-2 level [3 months]

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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

+Publications

Results publication: Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2. PMID 33283264

+Investigators

Jamshid Roozbeh, MD, Study chair, Shiraz University of Medical Sciences
Abdolali Mohagheghzadeh, PhD, Principal investigator, Shiraz University of Medical Sciences
Mohammad Mehdi Sagheb, MD, Principal investigator, Shiraz University of Medical Sciences
Arian Kamali-Sarvestani, Pharm D, Study director, Shiraz University of Medical Sciences
Pouya Faridi, PhD, Study director, Shiraz University of Medical Sciences