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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04660773
Other study ID # 0106476
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date August 1, 2021
Est. completion date March 1, 2022

Study information

Verified date July 2021
Source Alexandria University
Contact marwa eldeeb
Phone 01200029774
Email marwa.eldeeb16@alexmed.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients will be randomly assigned into 2 groups: 1. Group A: (20 patients) will receive NB UVB phototherapy 3 sessions per week for 2 months. 2. Group B: (20 patients) will receive pregabalin oral therapy (50mg after each dialysis session) for 2 months.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date March 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria: 1. Age: 20-60 years. 2. End stage renal disease (the last stage(stage 5) of chronic disease which means kidneys are only functioning at 10 to 15 percent of their normal capacity and dialysis or kidney transplant is necessary to stay alive). 3. Refractory uremic pruritis. Exclusion Criteria: 1. Other causes of pruritis (Dermatological or systemic) e.g. atopic, cholestatic liver disease. 2. Photosensitivity. 3. Contraindication or allergy to pregabalin. 4. Patients on antipruritic drugs e.g. antihistamines, steroids, emollients, opioid agonists.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
NB UVB phototherapy
ultraviolet phototherapy sessions
Drug:
Pregabalin
oral medication

Locations

Country Name City State
Egypt Faculty of Medicine Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 5 D-itching scale assessment of degree, duration, direction, disability and distribution of itching two month