Study of the effect of 6 % Gabapentin topical cream on uremic pruritus in maintenance hemodialysis patients a randomized double-blind placebo controlled clinical trial
Investigating the effect of 6% Gabapentin topical cream on uremic pruritus in chronic hemodialysis patients
Design
The clinical trial has a control group, with parallel groups, double-blind, randomized, on 68 patients. Randomization is done with https://www.sealedenvelope.com.
Settings and conduct
The study will be conducted at Razi Hospital in Rasht. The study will be conducted in two intervention and control groups. Participants and researchers will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients over 18 years of age undergoing hemodialysis treatment (at least 2 times a week and for at least 8 weeks) who scored higher than 5 on the 11-point VAS scale, were included in the study after obtaining informed consent.
Exclusion criteria: patients who have been treated with antihistamines and emollients, patient sensitivity to gabapentin or placebo, pregnancy, breastfeeding.
Intervention groups
Each patient is given a jar for 30 days. Group A receives gabapentin cream and group B receives placebo. Then the patients are asked to use 2 grams of the cream on the itchy area at night.
Main outcome variables
Duration of itching throughout the day, intensity of itching, quality of sleep, quality of social relationships, quality of presence at work or home or school and the number of areas affected by itching.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220516054879N8
Registration date:2023-11-04, 1402/08/13
Registration timing:registered_while_recruiting
Last update:2023-11-04, 1402/08/13
Update count:0
Registration date
2023-11-04, 1402/08/13
Registrant information
Name
maryam shahrokhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 9026
Email address
mshahrokhi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-20, 1402/07/28
Expected recruitment end date
2024-04-16, 1403/01/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of 6 % Gabapentin topical cream on uremic pruritus in maintenance hemodialysis patients a randomized double-blind placebo controlled clinical trial
Public title
Effects of topical Gabapentin 6% cream and placebo on uremic pruritus in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion 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:
Patients who have been treated with antihistamines and emollients.
Patient sensitivity to gabapentin or placebo
Pregnancy
Breastfeeding
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be entered into each of the 2 drug (A) and placebo (B) treatment groups using the block randomization method with a ratio of 1:1. Randomization will be done in such a way that each patient will be assigned number 1 to 68. Then a table that has 17 rows called blocks and each block will have 4 parts and each part will be named A and B will be considered. In the next step, the numbers are placed in each house in order. After all the numbers are placed in the blocks, the people who have numbers in house A will receive the drug and the people who have numbers in house B will receive placebo. The website https://www.sealedenvelope.com is used for randomization.
For allocation concealment, opaque-sealed envelopes will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind study. The type of treatment will be placed inside a sealed envelope and delivered to the nurse and statistical analyst. The researcher and the participant will be blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Deputy of research and technology, In front of 17 shahrivar hospital, Shaid siadati street,Namjoo street, Rasht
City
Rasht
Province
Guilan
Postal code
4193713111
Approval date
2023-10-18, 1402/07/26
Ethics committee reference number
IR.GUMS.REC.1402.374
Health conditions studied
1
Description of health condition studied
Uremic pruritus
ICD-10 code
L29.9
ICD-10 code description
Pruritus, unspecified
Primary outcomes
1
Description
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
2
Description
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
3
Description
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
4
Description
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
5
Description
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
6
Description
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 outcomes
1
Description
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
Intervention groups
1
Description
Intervention group: Receiving a 6% gabapentin topical cream once a day for 1 month
Category
Treatment - Drugs
2
Description
Control group: Receiving a placebo (cold cream) once a day for 1 month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Maryam Shahrokhi
Street address
Modafean Salamat Blvd, Razi Educational Remedial & Research Center
City
Rasht
Province
Guilan
Postal code
41448 95655
Phone
+98 13 3355 0028
Email
razi.hospital@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
محمدرضا نقی پور
Street address
In front of 17 shahrivar Hospital, Shahid Siadati Street, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4193713111
Phone
+98 13 3333 6394
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Maryam Shahrokhi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
17shahrivar Hospital, Shahid Siadati Street, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144654379
Phone
+98 13 3336 9019
Email
shahrokhi.mail85@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Maryam Shahrokhi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
17shahrivar Hospital, Shahid Siadati Street, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144654379
Phone
+98 13 3336 9019
Email
shahrokhi.mail85@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Sabah Sadat Moraghebi
Position
Pharmacy Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Unit 4, No.1174, Yousefi Alley, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144664145
Phone
+98 901 303 9671
Email
sabah.moraghebi1377@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Patient privacy and ethical principles
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
The results of the study will be available to everyone, specific information will be available only to the treatment staff. To protect the patient's privacy, the patient's information will be protected by the researcher.
When the data will become available and for how long
There is currently no plan to publish the data, but if published, it will be 6 months after the results are published.
To whom data/document is available
Researchers who are active in this field - Nerphrologists and scientific and qualified people
Under which criteria data/document could be used
Physicians and researchers will have the right to request, there are restrictions on patient privacy and medical ethics
From where data/document is obtainable
Dr. Maryam Shahrokhi, razi Hospital, Rasht; Sabah Sadat Moraghebi School of Pharmacy guilan university of meical science
What processes are involved for a request to access data/document
Refer to the razi Hospital in Rasht and sign the application form, then meet with the project researcher and review the client's request - consult with the Medical Ethics Committee, then provide documentation