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IRCT20250507065634N5 IRCT 2025-10-06 Bandare-abbas University of Medical Sciences 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 2025-10-23 anticipated 150 Complete https://irct.ir/trial/86459 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: Experimental and control groups: After selecting the sample, in the next step, people are divided into experimental and control groups using a random method. How to perform randomization: First step: After selecting the voluntary sample, all selected people are placed on a list (numbers from one to 150 are assigned to people). Second step: From these people, using a random method using sealed and opaque (numbered) envelopes, people are divided into experimental and control groups. Each person randomly selects an envelope and is divided into the corresponding group. 2-3 Uremic Pruritus. 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 study as the intervention group. This group will receive gabapentin. The starting dose of gabapentin will be 300 mg (Sobhan Daru Company) every other night after each dialysis session. In cases where inadequate response is defined as a decrease of less than 2 units in the visual analog scale (VAS) score after one week of treatment, the gabapentin dose will be increased to 300 mg per day. The severity of Pruritus and its impact on quality of life will be assessed at baseline and after 1 week, 2 weeks, and 4 weeks after the intervention, respectively, using the visual analog scale and the D-5 itching scale. Intervention 2: Control group: 75 hemodialysis patients of Shahid Mohammadi Hospital, Bandar Abbas, who suffer from Pruritus and meet the inclusion criteria, will be randomly assigned to participate in the study as the intervention group. This group will receive doxepin. The starting dose of doxepin will be 10 mg (Ramofarin Company) every night after each dialysis session. In cases where an inadequate response is defined as a decrease of less than 2 points in the visual analog scale (VAS) score after one week of treatment, the dose of doxepin will be increased to 10 mg twice a day. The severity of Pruritus and its impact on quality of life will be assessed at baseline and after 1 week, 2 weeks, and 4 weeks after the intervention, respectively, using the visual analog scale and the D-5 itching scale. Yes - There is a plan to make this available What will be shared: Demographic data and the main outcome results of the research can be shared after de-identification and preserving the privacy of individuals. When: Data can be made available 4 months after the results are published and after personally identifiable information is removed. To whom: The study data and documentation will be available to researchers and scholars working at reputable academic and scientific institutions. Conditions: Research data and documentation may be used for scientific and research purposes. Users must undertake to keep non-identifiable data confidential. Where to obtain: If you need data, please contact Amirahmadshojaei76@gmail.com How to obtain: After receiving and reviewing the request from the researcher, the request will be responded to as soon as possible. Comments:
public AmirAhmad Shojaei
Unit 36, 6th Floor, Khorshid Building, Goharan 20, Damahi Street, Bandar Abbas, Hormozgan, Iran
Bandar Abas Iran (Islamic Republic of) ۷۹۱۵۳-۱۵۵۳۵ +98 933 686 5210 Amirahmadshojaei76@gmail.com Bandare-abbas University of Medical Sciences scientific Maryam Farokh Shahi
Payambar-e Azam Educational and Therapeutic Complex, Opposite District 3 Municipality, Jomhouri Eslami Boulevard, Bandar Abbas, Hormozgan, Iran
Bandar Abas Iran (Islamic Republic of) 15519-79199 +98 914 032 7395 dr.maryamfarokhshahii@gmail.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Diagnosis of End-Stage Renal Disease (ESRD) Hospitalization and undergoing hemodialysis Willingness to participate in the study (informed consent) 16 years 80 years Male 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). L29.8 Other pruritus Diagnosis Diagnosis 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 study as the intervention group. This group will receive gabapentin. The starting dose of gabapentin will be 300 mg (Sobhan Daru Company) every other night after each dialysis session. In cases where inadequate response is defined as a decrease of less than 2 units in the visual analog scale (VAS) score after one week of treatment, the gabapentin dose will be increased to 300 mg per day. The severity of Pruritus and its impact on quality of life will be assessed at baseline and after 1 week, 2 weeks, and 4 weeks after the intervention, respectively, using the visual analog scale and the D-5 itching scale. Control group: 75 hemodialysis patients of Shahid Mohammadi Hospital, Bandar Abbas, who suffer from Pruritus and meet the inclusion criteria, will be randomly assigned to participate in the study as the intervention group. This group will receive doxepin. The starting dose of doxepin will be 10 mg (Ramofarin Company) every night after each dialysis session. In cases where an inadequate response is defined as a decrease of less than 2 points in the visual analog scale (VAS) score after one week of treatment, the dose of doxepin will be increased to 10 mg twice a day. The severity of Pruritus and its impact on quality of life will be assessed at baseline and after 1 week, 2 weeks, and 4 weeks after the intervention, respectively, using the visual analog scale and the D-5 itching scale. 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. Bandare-abbas University of Medical Sciences Approved 2025-08-27 Research Ethics Committees of Hormozgan University of Medical Sciences Deputy of research and technology, campus of Hormozgan University of Medical Sciences, Imam Hossein boulevard, Bandar Abas, Iran BandarAbas Hormozgan Iran (Islamic Republic of)