The effect of locally administered Sambucus ebulus gel 5% on the severity and extention of pruritus in hemodialysis patients

Phase 2

Recruiting

• Conditions: Pruritus, unspecified; Pruritus in hemodialysis patients.; L29.9

• Registration Number: IRCT20191231045958N1
• Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 May 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Patients over 18 years who have been undergoing hemodialysis for more than 3 months
Patients who have had itching at least 3 times in the last 2 weeks
Despite drug use in the last month of treatment, no evidence of improvement was observed
Patients undergo hemodialysis 3 days a week for 3–5 hours per session
Have no skin problems other than uremic itching
Patients who gave their written consent to participate in the project
Patients who do not use another method to reduce the severity of itching
Lack of systemic diseases such as liver cholestatic, hepatitis B, HIV thyroid disorders and women who are not pregnant and breastfeeding
Lack of cognitive impairments that cannot answer questions

Exclusion Criteria

If the patient undergoes kidney transplantation during the study
If there is allergy to sambucus ebulus gel
Patients who do not wish to continue the study for personal reasons
Patients with a phosphorus test range of more than 6 and a PTH of more than 300

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pruritus. Timepoint: first visit-The fourth and eighth week after starting to use the gel. Method of measurement: 48-point scale for itching severity.

Secondary Outcome Measures

Name	Time	Method
Skin dryness. Timepoint: first week, The fourth and eighth week after starting to use the gel. Method of measurement: Examination.