Evaluating the Effect of Senna in Uremic Pruritus
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
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 1, 2013
CompletedFirst Posted
Study publicly available on registry
December 11, 2013
CompletedApril 1, 2015
March 1, 2015
1.1 years
December 1, 2013
March 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Severity of Pruritis, as measured by a visual analogue scale
A '0' score represented absence of pruritus and a '10' represented the greatest severity of symptoms.
3 months
Secondary Outcomes (1)
Serum IL-2 level
3 months
Study Arms (2)
Placebo
PLACEBO COMPARATORWheat
Senna
ACTIVE COMPARATORSenna
Interventions
Eligibility Criteria
You may qualify if:
- Hemodialysis patients
- Suffering from pruritus for at least 6 weeks
- Have not responded to other drugs
You may not qualify if:
- Dermatological disease
- Liver disease
- Metabolic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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: 33283264DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
December 1, 2013
First Posted
December 11, 2013
Study Start
August 1, 2011
Primary Completion
September 1, 2012
Last Updated
April 1, 2015
Record last verified: 2015-03