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The Effect of Doxepin and Gabapentin in the Management of Uremic Pruritus

Comparison of the Effect of Doxepin and Gabapentin in the Management of Uremic Pruritus in Hemodialysis Patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250507065634N5
Enrollment
150
Registered
2025-10-06
Start date
2025-10-23
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uremic Pruritus. Other pruritus

Interventions

Intervention 1: Intervention group: 75 hemodialysis patients of Shahid Mohammadi Hospital, Bandar Abbas, who suffer from Pruritus and meet the inclusion criteria, will be randomly assigned to the stud

Sponsors

Bandare-abbas University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
16 Years to 80 Years

Inclusion criteria

Inclusion criteria: Diagnosis of End-Stage Renal Disease (ESRD) Hospitalization and undergoing hemodialysis Willingness to participate in the study (informed consent)

Exclusion criteria

Exclusion criteria: Patients with hepatic failure Hyperthyroidism Angle-closure glaucoma Heart block Decompensated heart failure Hypotension History of hypersensitivity to gabapentin or doxepin Uncontrolled psychiatric disorders Myocardial infarction within the past three months Epilepsy, history of even a single seizure, or pregnancy Patients with psoriasis, atopic dermatitis, or any other condition that could explain pruritus Contraindications to Gabapentin include: Renal impairment; Psychiatric or mood disorders such as depression and suicidal ideation; Substance or alcohol abuse; Respiratory disorders. Contraindications to Doxepin: Bleeding disorders; Recent myocardial infarction; Urinary disorders such as prostatic hypertrophy; Personal or family history of angle-closure glaucoma; Personal or family history of psychiatric or mood disorders (e.g., bipolar disorder, psychosis); Family history of suicide; Seizures or conditions that may increase the risk of seizures (e.g., other brain disorders, alcohol/sedative withdrawal).

Design outcomes

Primary

MeasureTime frame
Pruritus Severity. Timepoint: Before the intervention and after 1 week, 2 weeks and 4 weeks after the intervention. Method of measurement: Using the Visual Analogue Scale.;Impact of Pruritus on Quality of Life. Timepoint: Before the intervention and after 1 week, 2 weeks and 4 weeks after the intervention. Method of measurement: Using the 5-D Itch Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmirAhmad Shojaei

Bandare-abbas University of Medical Sciences

Amirahmadshojaei76@gmail.com+98 933 686 5210

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026