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Evaluating the Effect of Senna in Uremic Pruritus

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ClinicalTrials.gov Identifier: NCT02008864
Recruitment Status : Completed
First Posted : December 11, 2013
Last Update Posted : April 1, 2015
Sponsor:
Information provided by (Responsible Party):
Pouya Faridi, 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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Pruritus Drug: Senna Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2011
Actual Primary Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Severity of Pruritis, as measured by a visual analogue scale [ Time Frame: 3 months ]
    A '0' score represented absence of pruritus and a '10' represented the greatest severity of symptoms.


Secondary Outcome Measures :
  1. Serum IL‐2 level [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02008864


Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
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Study Chair: Jamshid Roozbeh, MD Shiraz University of Medical Sciences
Principal Investigator: Abdolali Mohagheghzadeh, PhD Shiraz University of Medical Sciences
Principal Investigator: Mohammad Mehdi Sagheb, MD Shiraz University of Medical Sciences
Study Director: Arian Kamali-Sarvestani, Pharm D Shiraz University of Medical Sciences
Study Director: Pouya Faridi, PhD Shiraz University of Medical Sciences

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Responsible Party: Pouya Faridi, Dr., Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02008864     History of Changes
Other Study ID Numbers: Senna in Uremic Pruritus
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015

Keywords provided by Pouya Faridi, Shiraz University of Medical Sciences:
End stage renal diseases
Hemodialysis
Uremic pruritus
Iranian traditional medicine
Cassia angustifolia

Additional relevant MeSH terms:
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Sennoside A&B
Kidney Diseases
Kidney Failure, Chronic
Pruritus
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Skin Diseases
Skin Manifestations
Signs and Symptoms
Cathartics
Gastrointestinal Agents