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

Protocol summary

Study aim
Comparison of the effects of doxepin and gabapentin in the treatment of uremic pruritus in hemodialysis patients
Design
This clinical trial study was a controlled, parallel-group, unblinded, and randomized (sealed envelope) study. The study was conducted on 150 hemodialysis patients with uremic pruritus symptoms at Shahid Mohammadi Hospital in Bandar Abbas. The sealed envelope method was used for randomization.
Settings and conduct
This study will be conducted on 150 hemodialysis patients at Shahid Mohammadi Hospital in Bandar Abbas, and eligible patients will be randomly assigned to two intervention groups (gabapentin) and a control group (doxepin). The severity of itching and its impact on quality of life will be assessed at baseline and at weeks 1, 2, and 4 after treatment using the Visual Analogue Scale (VAS) and the 5-D Itch Scale.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Diagnosis of End-Stage Renal Disease (ESRD); Hospitalization and undergoing hemodialysis; Willingness to participate in the study Exclusion Criteria: Hepatic failure, hyperthyroidism, angle-closure glaucoma, heart block, decompensated heart failure, hypotension; History of hypersensitivity to gabapentin or doxepin; Uncontrolled psychiatric disorders, severe depression, or suicidal ideation; Myocardial infarction within the past three months; Epilepsy or any history of seizure, pregnancy; Skin conditions that could explain pruritus (psoriasis, atopic dermatitis, etc.); Gabapentin contraindications, doxepin contraindications
Intervention groups
Intervention group: 75 hemodialysis patients with pruritus symptoms and eligible for inclusion who receive a dose of gabapentin 300 mg. Control group 2: 75 hemodialysis patients with pruritus symptoms and eligible for inclusion who receive a dose of doxepin 10 mg.
Main outcome variables
Pruritus Severity: Impact of Pruritus on Quality of Life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250507065634N5
Registration date: 2025-10-06, 1404/07/14
Registration timing: prospective

Last update: 2025-10-06, 1404/07/14
Update count: 0
Registration date
2025-10-06, 1404/07/14
Registrant information
Name
mahnaz shafaei fallah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 930 0704
Email address
articlelab.com@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-23, 1404/08/01
Expected recruitment end date
2025-12-01, 1404/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Doxepin and Gabapentin in the Management of Uremic Pruritus in Hemodialysis Patients
Public title
The Effect of Doxepin and Gabapentin in the Management of Uremic Pruritus
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of End-Stage Renal Disease (ESRD) Hospitalization and undergoing hemodialysis Willingness to participate in the study (informed consent)
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).
Age
From 16 years old to 80 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Hormozgan University of Medical Sciences
Street address
Deputy of research and technology, campus of Hormozgan University of Medical Sciences, Imam Hossein boulevard, Bandar Abas, Iran
City
BandarAbas
Province
Hormozgan
Postal code
7919692004
Approval date
2025-08-27, 1404/06/05
Ethics committee reference number
IR.HUMS.REC.1403.220

Health conditions studied

1

Description of health condition studied
Uremic Pruritus
ICD-10 code
L29.8
ICD-10 code description
Other pruritus

Primary outcomes

1

Description
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

2

Description
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

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Diagnosis

2

Description
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.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital, Bandar Abbas
Full name of responsible person
Ehsan Ramezanian Nik
Street address
Shahid Mohammadi Hospital, Eastern Wing, Payambar-e Azam Complex, Jomhouri Eslami Boulevard, Bandar Abbas, Hormozgan, Iran
City
Bandar Abas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 7611
Email
info@hums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Sharam Zare
Street address
Deputy of research and technology, campus of Hormozgan University of Medical Sciences, Imam Hossein boulevard, Bandar Abas, Iran
City
Bandar Abas
Province
Hormozgan
Postal code
7919692004
Phone
+98 76 3128 1680
Email
research@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
AmirAhmad Shojaei
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Unit 36, 6th Floor, Khorshid Building, Goharan 20, Damahi Street, Bandar Abbas, Hormozgan, Iran
City
Bandar Abas
Province
Hormozgan
Postal code
۷۹۱۵۳-۱۵۵۳۵
Phone
+98 933 686 5210
Email
Amirahmadshojaei76@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Maryam Farokh Shahi
Position
Assistant Professor of Dermatology, Hormozgan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Payambar-e Azam Educational and Therapeutic Complex, Opposite District 3 Municipality, Jomhouri Eslami Boulevard, Bandar Abbas, Hormozgan, Iran
City
Bandar Abas
Province
Hormozgan
Postal code
15519-79199
Phone
+98 914 032 7395
Email
dr.maryamfarokhshahii@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
AmirAhmad Shojaei
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Unit 36, 6th Floor, Khorshid Building, Goharan 20, Damahi Street, Bandar Abbas, Hormozgan, Iran
City
Medical student
Province
Hormozgan
Postal code
۷۹۱۵۳-۱۵۵۳۵
Phone
+98 933 686 5210
Email
Amirahmadshojaei76@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic data and the main outcome results of the research can be shared after de-identification and preserving the privacy of individuals.
When the data will become available and for how long
Data can be made available 4 months after the results are published and after personally identifiable information is removed.
To whom data/document is available
The study data and documentation will be available to researchers and scholars working at reputable academic and scientific institutions.
Under which criteria data/document could be used
Research data and documentation may be used for scientific and research purposes. Users must undertake to keep non-identifiable data confidential.
From where data/document is obtainable
If you need data, please contact Amirahmadshojaei76@gmail.com
What processes are involved for a request to access data/document
After receiving and reviewing the request from the researcher, the request will be responded to as soon as possible.
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