Comparison of efficacy and safety of empagliflozin with placebo in patients with idiopathic edema
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, on 70 patients. The randomization of patients will be done with the block randomization method using block of size 4
Settings and conduct
This research is a randomized double-blind controlled clinical trial that will be conducted on patients with idiopathic edema referred to nephrology clinics in Ahvaz and Dezful, and to prevent bias until the end of the research, all members of the treatment and research team will not be aware of the codes (drug type) and after the end of the treatment, the codes will be opened
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients over 18 years of age who suffers from generalized edema and in the diagnostic examinations, there is no justifying disorder and the cause of generalized edema for the patient; The patient does not take drugs that cause edema. Non-inclusion criteria: patients who do not want to cooperate and participate in the research or withdraw during the research; menopause (in women)
Intervention groups
Intervention group: There are patients who are treated with empagliflozin tablets.
Control group: There are patients who receive placebo.
Main outcome variables
The amount of edema
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230314057712N1
Registration date:2023-08-19, 1402/05/28
Registration timing:registered_while_recruiting
Last update:2023-08-19, 1402/05/28
Update count:0
Registration date
2023-08-19, 1402/05/28
Registrant information
Name
Shokouh Shayanpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 916 311 4638
Email address
shayanpour-sh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and safety of empagliflozin with placebo in patients with idiopathic edema
Public title
The effect of empagliflozin in patients with idiopathic edema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years of age who refer due to generalized edema
The patient does not take drugs that cause edema
In the diagnostic investigations, there are no disorders, including kidney, heart, liver, thyroid, etc. There should be no justification and cause of generalized edema for the patient
Exclusion criteria:
Patients who do not want to cooperate and participate in the research
Patients with diseases such as advanced renal failure, liver failure, chronic or recurrent UTI
Patients with immune deficiency or diabetes
Patients who use drugs that interfere with the intervention process
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
At the beginning of the research, the patients will be divided into two groups of case and control (35 people each) through block randomization with spss type 23 software and using blocks of size 4, and block randomization is for the purpose of making sure Exactly equal number of participants are included in the intervention and control group at consecutive but equal time intervals
Blinding (investigator's opinion)
Double blinded
Blinding description
The placebo will be completely with the same color and similar to the original drug and its packaging will be completely similar to the original drug, and then the drug (empagliflozin) and the placebo will be coded by the pharmacist. To prevent bias until the end of the research, all members of the treatment and research team will be unaware of the codes, and the codes will be unlocked after the treatment process is over
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of َAhvaz jundishapur University of Medical Sciences
Street address
Imam Khomeini Hospital; Azadegan street
City
Ahvaz
Province
Khouzestan
Postal code
61936673111
Approval date
2023-03-11, 1401/12/20
Ethics committee reference number
IR.AJUMS.REC.1401.590
Health conditions studied
1
Description of health condition studied
Idiopathic edema
ICD-10 code
R60.9
ICD-10 code description
Edema, unspecified
Primary outcomes
1
Description
The amount of edema
Timepoint
At the beginning of the study, 2, 6 and 12 weeks after starting the mentioned drug
Method of measurement
TANITA body analysis device
Secondary outcomes
1
Description
The amount of physical activity in the International Physical Activity Questionnaire
Timepoint
before the intervention and then at the end of the second, sixth and twelfth weeks
Method of measurement
International Physical Activity Questionnaire
Intervention groups
1
Description
Intervention group: For patients in the main group, empagliflozin 10 mg tablets manufactured by Abidi Pharmaceutical Company in Iran are prescribed. One empagliflozin tablet with 50 cc of water will be prescribed once a day and after lunch for 12 weeks. To control the correct use of the drug and placebo by the patients, the drug will be delivered to the patients on a weekly basis and at the end of the week, the empty blisters will be collected from the patients and counted. If more than 20% of the drug or placebo is not consumed, the patient will be removed from the study.
Category
Treatment - Drugs
2
Description
Control group: Control group patients will be prescribed 10 mg of placebo drug along with 50 cc of water once a day after lunch for 12 weeks. It will be delivered and at the end of the week, the empty blisters will be collected from the patients and counted. The placebo will be produced at Jundishapur Faculty of Pharmacy in Ahvaz, and it will be similar to the original drug in terms of all physical and appearance characteristics and packaging. The placebo compounds include It will be Avisel
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini Hospital
Full name of responsible person
Shokouh Shayanpour
Street address
24 Metery street, East Sahely highway
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 916 311 4638
Email
shayanpour-sh@ajums.ac.ir
2
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Shokouh Shayanpour
Street address
Golestan Hospital; Golestan district
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 916 311 4638
Email
shayanpour-sh@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
24 metery street, East Sahely highway
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 916 311 4638
Fax
+98 916 311 4638
Email
shayanpour-sh@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Shokouh Shayanpour
Position
Assistant Professor of Nephrology
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital; Azadegan St. (24 Metery)
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 916 311 4638
Fax
Email
shayanpour-sh@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shokouh Shayanpour
Position
Assistant Professor of Nephrology
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital; Azadegan St. (24 Metery)
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 916 311 4638
Fax
Email
shayanpour-sh@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shokouh Shayanpour
Position
Assistant Professor of Nephrology
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital; Azadegan St. (24 Metery)
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 916 311 4638
Fax
Email
shayanpour-sh@ajums.ac.ir
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
Still undecided - no release schedule yet.
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
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