Determining the effect of topical piroxicam on uremic pruritus in hemodialysis patients
Design
A clinical trial with a control group, with a parallel-group, double-blind, randomized, phase 3 on 50 patients, the table of random numbers obtained from the RAND function of Excel software is used for randomization.
Settings and conduct
ُStudy place: Shahid Rahnamon Hospital, Yazd. Patients who meet the inclusion criteria are placed in one of the two treatment groups with piroxicam gel (group A) or basic gel (group B). Randomization is done based on the RAND() function of Excel software. Based on this, a table of random numbers is prepared, and the patients are placed in groups A or B according to the rows of this table and receive the product related to their group. the numbered Gels will be available to the attending physician and them. Patients are evaluated on days 1, 7 and 14.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients aged 18-70 years; suffering from uremic pruritus with localized uremic pruritus; without a history of piroxicam allergy; not pregnant or breastfeeding.
Exclusion criteria: aggravation of the disease; not taking the medicine for more than two days in a row; causing unwanted side effects from the medicine; unwillingness of the participant to continue cooperation.
Intervention groups
Intervention group: treatment with 0.5% piroxicam gel, once a day, topical application for up to 2 weeks. Control group: treatment with placebo gel (lubricant gel), once a day, topical application for up to 2 weeks.
Main outcome variables
Pruritus score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191106045356N18
Registration date:2023-07-25, 1402/05/03
Registration timing:retrospective
Last update:2023-07-25, 1402/05/03
Update count:0
Registration date
2023-07-25, 1402/05/03
Registrant information
Name
Mohsen Zabihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3865
Email address
mzabihi100@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-06, 1401/12/15
Expected recruitment end date
2023-05-05, 1402/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical piroxicam in the treatment of uremic pruritus: A randomized double-blinded placebo control clinical trial
Public title
The effect of topical piroxicam in the treatment of uremic pruritus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing hemodialysis more than 3 times a month
Insensitivity to piroxicam
Patients with chronic uremic pruritus
Absence of pregnancy and breastfeeding
Exclusion criteria:
Patients with underlying skin disease
Allergic to Piroxicam
Pregnancy
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to one of the two groups of piroxicam gel and placebo based on the RAND function of Excel software in the order of entry into the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be done in a double-blind manner.
Patients and doctors (therapist and evaluator) will not know about the intervention.
Piroxicam gel and Base gel are numbered by one of the researchers who does not intervene in the study process (treatment, evaluation, and data analysis) with labels one and two, and only the same researcher knows about the numbering of worms. Then the numbered gels are delivered to the patients by the doctor.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2023-06-26, 1402/04/05
Ethics committee reference number
IR.SSU.MEDICINE.REC.1402.094
Health conditions studied
1
Description of health condition studied
Uremic pruritus
ICD-10 code
L29
ICD-10 code description
Pruritus
Primary outcomes
1
Description
Uremic pruritus
Timepoint
?Before intervention and 7, 14 days after intervention
Method of measurement
Pruritus questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 25 patients with uremic pruritus treated with 0.5% piroxicam gel (manufactured by a domestic pharmaceutical company), topical application, once a day for 14 days.
Category
Treatment - Drugs
2
Description
Control group: 25 patients with uremic itching who were treated with base gel (lubricant gel made by a domestic pharmaceutical company), topical application, once a day for 14 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rahnemon Hospital
Full name of responsible person
ِDr. Mahdi Zahmatkesh
Street address
Farokhi st.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3822 4000
Email
mzabihi100@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3822 4000
Email
mzabihi100@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice President of Research and Technology, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
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
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
mzabihi100@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
mzabihi100@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
mzabihi100@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available