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IRCT20230314057712N1 IRCT 2023-08-19 Ahvaz University of Medical Sciences The effect of empagliflozin in patients with idiopathic edema Comparison of efficacy and safety of empagliflozin with placebo in patients with idiopathic edema 2023-04-21 anticipated 70 Complete https://irct.ir/trial/69154 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 4 Idiopathic edema. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is Still undecided - no release schedule yet.
public Shokouh Shayanpour
Imam Khomeini Hospital; Azadegan St. (24 Metery)
Ahvaz Iran (Islamic Republic of) 6193673166 +98 916 311 4638 shayanpour-sh@ajums.ac.ir Ahvaz University of Medical Sciences scientific Shokouh Shayanpour
Imam Khomeini Hospital; Azadegan St. (24 Metery)
Ahvaz Iran (Islamic Republic of) 6193673166 +98 916 311 4638 shayanpour-sh@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years no limit Both 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 R60.9 Edema, unspecified Treatment - Drugs Placebo 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. 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 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. 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. Ahvaz University of Medical Sciences Approved 2023-03-11 Ethics committee of ŮŽAhvaz jundishapur University of Medical Sciences Imam Khomeini Hospital; Azadegan street Ahvaz Khouzestan Iran (Islamic Republic of)