PHOTOTHERAPY VERSUS PREGABALIN IN TREATMENT OF REFRACTORY UREAMIC PRURITIS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Refractory Uremic Pruritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NB UVB phototherapy

(20 patients) will receive NB UVB phototherapy 3 sessions per week for 2 months.

Group Type ACTIVE_COMPARATOR

NB UVB phototherapy

Intervention Type DEVICE

ultraviolet phototherapy sessions

pregabalin

20 patients) will receive pregabalin oral therapy (50mg after each dialysis session) for 2 months.

Group Type ACTIVE_COMPARATOR

Pregabalin

Intervention Type DRUG

oral medication

Interventions

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NB UVB phototherapy

ultraviolet phototherapy sessions

Intervention Type DEVICE

Pregabalin

oral medication

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No