Effects of topical Gabapentin 6% cream and placebo on uremic pruritus in hemodialysis patients

Study of the effect of 6 % Gabapentin topical cream on uremic pruritus in maintenance hemodialysis patients a randomized double-blind placebo controlled clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220516054879N8

Enrollment

Registered

2023-11-04

Start date

2023-10-20

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Uremic pruritus. Pruritus, unspecified

Interventions

Intervention 1: Intervention group: Receiving a 6% gabapentin topical cream once a day for 1 month. Intervention 2: Control group: Receiving a placebo (cold cream) once a day for 1 month.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients over 18 years old who are undergoing hemodialysis treatment (at least 2 times a week and for at least 8 weeks). Patients who scored higher than 5 in the 11-point VAS scale. Obtaining informed consent

Exclusion criteria

Exclusion criteria: Patients who have been treated with antihistamines and emollients. Patient sensitivity to gabapentin or placebo Pregnancy Breastfeeding

Design outcomes

Primary

Measure	Time frame
Duration of itching during the day and night. Timepoint: The duration of itching during the day and night is measured at the beginning of the study and then in the second and fourth weeks. Method of measurement: Based on questions from the patient using the 5D-itch questionnaire.;Intensity of itching. Timepoint: The intensity of itching is measured at the beginning of the study and then in the second and fourth weeks. Method of measurement: Based on questions from the patient using the 5D-itch questionnaire.;Sleep quality. Timepoint: The effect of itching on sleep quality is measured at the beginning of the study and then in the second and fourth weeks. Method of measurement: Based on questions from the patient using the 5D-itch questionnaire.;Quality of social relationships. Timepoint: The effect of itching on the quality of social relationships is measured at the beginning of the study and then in the second and fourth weeks. Method of measurement: Based on questions from the patient using the 5D-itch questionnaire.;Quality of presence at work or home. Timepoint: The effect of itching on the quality of being at work or at home is measured at the beginning of the study and then in the second and fourth weeks. Method of measurement: Based on questions from the patient using the 5D-itch questionnaire.;The number of areas affected by itching. Timepoint: The effect of the number of areas affected by itching is measured at the beginning of the study and then in the second and fourth weeks. Method of measurement: Based on questions from the patient using the 5D-itch questionnaire.	—

Measure

Time frame

Duration of itching during the day and night. Timepoint: The duration of itching during the day and night is measured at the beginning of the study and then in the second and fourth weeks. Method of measurement: Based on questions from the patient using the 5D-itch questionnaire.;Intensity of itching. Timepoint: The intensity of itching is measured at the beginning of the study and then in the second and fourth weeks. Method of measurement: Based on questions from the patient using the 5D-itch questionnaire.;Sleep quality. Timepoint: The effect of itching on sleep quality is measured at the beginning of the study and then in the second and fourth weeks. Method of measurement: Based on questions from the patient using the 5D-itch questionnaire.;Quality of social relationships. Timepoint: The effect of itching on the quality of social relationships is measured at the beginning of the study and then in the second and fourth weeks. Method of measurement: Based on questions from the patient using the 5D-itch questionnaire.;Quality of presence at work or home. Timepoint: The effect of itching on the quality of being at work or at home is measured at the beginning of the study and then in the second and fourth weeks. Method of measurement: Based on questions from the patient using the 5D-itch questionnaire.;The number of areas affected by itching. Timepoint: The effect of the number of areas affected by itching is measured at the beginning of the study and then in the second and fourth weeks. Method of measurement: Based on questions from the patient using the 5D-itch questionnaire.

—

Secondary

Measure	Time frame
General condition of uremic itching in patients during one month. Timepoint: The general condition of uremic itching of patients is measured at the beginning of the treatment and then in the second and fourth weeks. Method of measurement: Based on asking the patient using the VAS scale.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Shahrokhi

Rasht University of Medical Sciences

shahrokhi.mail85@gmail.com+98 13 3336 9019

Outcome results

None listed

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