To compare the efficacy of pregabalin and sertraline in treating uremic pruritus
Design
Randomized clinical trial
Settings and conduct
This single-center clinical trial would be conducted at the Pak Emirates Military Hospital (Dialysis Unit).
All patients to provide consent.
Patients to be randomized to receive either Pregabalin or Sertraline.
Urdu version of the 5-D Itch Scale would be self-administered to assess severity of itching at baseline, and at 6 weeks post commencement of treatment.
Participants/Inclusion and exclusion criteria
Patients of both genders having age ≥19 years, on twice weekly HD for ESRD for at least six months, and having UP for at least six weeks, were included in this study. Exclusion criteria included dermatological or systemic diseases associated with pruritis, mental health issues affecting the ability to respond to the 5-D Itch Scale, and patients on a thrice-a-week HD schedule. Moreover, individuals already on some treatment for UP were generally excluded, except for patients on oral anti-histamines, for whom there was a washout period of two weeks before participation in this study
Intervention groups
The Pregabalin group would be given Pregabalin 75mg once a day orlly, while Sertraline Group would be given sertraline 50mg once a day orally.
Main outcome variables
Change in the severity of pruritus after six weeks of intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240208060941N1
Registration date:2024-02-14, 1402/11/25
Registration timing:retrospective
Last update:2024-02-14, 1402/11/25
Update count:0
Registration date
2024-02-14, 1402/11/25
Registrant information
Name
Muhammad Iqbal
Name of organization / entity
Pak Emirates Military Hospital/ National University of Medical Sciences
Country
Pakistan
Phone
+92 342 7007463
Email address
iqbalkharal2934@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-01, 1402/07/09
Expected recruitment end date
2023-12-01, 1402/09/10
Actual recruitment start date
2023-10-06, 1402/07/14
Actual recruitment end date
2023-12-13, 1402/09/22
Trial completion date
2024-01-31, 1402/11/11
Scientific title
Comparison between Pregabalin and Sertraline for treatment of Uremic Pruritus
Public title
Comparison between Pregabalin and Sertraline for treatment of itching in kidney failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients from both genders greater than 18 years of age
Patients on twice weekly hemodialysis for at least 6 months
Patients having uremic pruritus for more than 6 weeks
Exclusion criteria:
Patients with dermatological or systemic diseases associated with pruritis (such as acute hepatitis, chronic liver disease, pregnancy, and hypothyroidism)
Patients with mental health issues affecting their ability to respond to the 5-D Itch Scale (such as psychosis, obsessive-compulsive disorder, or substance abuse)
Patients on thrice-a-week haemodialysis schedule
Not consenting to participate
Age
From 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
46
Actual sample size reached:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done using computer generated sequences, prepared online
Blinding (investigator's opinion)
Single blinded
Blinding description
The 5-D itch Scale questionnaire would be self-administered, but the first author of this study would be available to answer patients’ queries and to ensure that there was is missing data on these forms. He would remain blinded to treatment being given.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Comittee Pak Emirates Military Hospital Rawalpindi
Street address
Pak Emirates Military Hospital, Mall Road
City
Rawalpindi
Postal code
46000
Approval date
2023-05-10, 1402/02/20
Ethics committee reference number
A/28/EC/535/23
Health conditions studied
1
Description of health condition studied
end stage renal disease
ICD-10 code
N18.6
ICD-10 code description
End stage renal disease
Primary outcomes
1
Description
Change in severity of pruritis
Timepoint
6 weeks post initiation of treatment
Method of measurement
The 5-D Itch Scale (Urdu version)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Pregabalin group
Category
Treatment - Drugs
2
Description
Intervention group 2: Sertraline group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pak Emirates Military Hospital Rawalpindi
Full name of responsible person
Muhammad Iqbal
Street address
Pak Emirates Military Hospital, Abid Majeed Road
City
Rawalpindi
Postal code
46000
Phone
+92 342 7007463
Email
Iqbalkharal2934@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Muhammad Iqbal
Street address
Abid Majeed Road
City
Rawalpindi
Postal code
46000
Phone
+92 342 7007463
Email
Iqbalkharal2934@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pak Emirates Military Hospital
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
Pak Emirates Military Hospital
Full name of responsible person
Muhammad Iqbal
Position
Registrar Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Department of Medicine, Pak Emirates Military Hospital, Abid Majeed Road
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 342 7007463
Email
Iqbalkharal2934@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Muhammad Iqbal
Position
Registrar Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Department of Medicine, Pak Emirates Military Hospital, Abid Majeed Road
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 342 7007463
Email
Iqbalkharal2934@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Muhammad Iqbal
Position
Registrar Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Department of Medicine, Pak Emirates Military Hospital, Abid Majeed Road
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 342 7007463
Email
Iqbalkharal2934@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The Deidentified Individual Participant Data Set, Study Protocol, Statistical Analysis Plan, and Informed Consent forms will be made available to desirous researchers upon reasonable requests, and after clearance from the institutional data registry body. The said documents will be shared in a non-editable format via email after scrutinizing the need for subject documents by the requesting authorities.
When the data will become available and for how long
The above-mentioned documents will be available after December 2024 for 10 years as per institutional data registry protocols.
To whom data/document is available
The data will be available only for non-commercial research purposes and will be provided to academic institutions only.
Under which criteria data/document could be used
The data/ document can be used for literary and non-commercial purposes.
From where data/document is obtainable
The Data can be obtained via email from:
Dr Muhammad Iqbal
Department of Medicine, Pak Emirates Military Hospital, Abid Majeed Road, Rawalpindi, Punjab, Pakistan, 46000.
Email: iqbalkharal2934@gmail.com
What processes are involved for a request to access data/document
Data requests can be directly made to Dr Muhammad Iqbal via email provided earlier. After the request is received, it will submitted to the Institutional Data Control and Registry Committee for necessary verification and clearance of the requested documents. Any additional information required by the committee will be forwarded to the requestee via email. After satisfying requirements of the Institutional Data Control and Registry Committee, the requested data/ documents will shared with the requesting person via suitable means. This process may take up to 6 weeks from the date of reception of the request.