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Evaluating the Effect of Senna in Uremic Pruritus

Primary Purpose

End Stage Renal Disease, Pruritus

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Senna

Placebo

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring End stage renal diseases, Hemodialysis, Uremic pruritus, Iranian traditional medicine, Cassia angustifolia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Senna

Arm Description

Wheat

Senna

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Serum IL-2 level

Full Information

NCT ID

NCT02008864

First Posted

December 1, 2013

Last Updated

March 30, 2015

Sponsor

Shiraz University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02008864

Brief Title

Evaluating the Effect of Senna in Uremic Pruritus

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 Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease, Pruritus

Keywords

End stage renal diseases, Hemodialysis, Uremic pruritus, Iranian traditional medicine, Cassia angustifolia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Wheat

Arm Title

Senna

Arm Type

Active Comparator

Arm Description

Senna

Intervention Type

Drug

Intervention Name(s)

Senna

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo tablet/ 2 times per day

Primary Outcome Measure Information:

Title

Severity of Pruritis, as measured by a visual analogue scale

Description

A '0' score represented absence of pruritus and a '10' represented the greatest severity of symptoms.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Serum IL-2 level

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jamshid Roozbeh, MD

Organizational Affiliation

Shiraz University of Medical Sciences

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Abdolali Mohagheghzadeh, PhD

Organizational Affiliation

Shiraz University of Medical Sciences

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mohammad Mehdi Sagheb, MD

Organizational Affiliation

Shiraz University of Medical Sciences

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Arian Kamali-Sarvestani, Pharm D

Organizational Affiliation

Shiraz University of Medical Sciences

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Pouya Faridi, PhD

Organizational Affiliation

Shiraz University of Medical Sciences

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

33283264

Citation

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.

Results Reference

derived

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Evaluating the Effect of Senna in Uremic Pruritus

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