]>
IRCT20221007056110N1 IRCT 2022-10-25 Bagheiat-allah University of Medical Sciences Effect of nanocurcumin in heart failure The effect and safety of nanocurcumin on patients with heart failure reduced EF (HFrEF) 2022-10-23 anticipated 60 Complete https://irct.ir/trial/66259 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted blocks method using the site https://www.sealedenvelope.com will be used. Each block has six components. The form of the blocks can be as follows for example: [ABAABAB], [BBABAA], [BABABA], ..... Codes A and B are randomly assigned to intervention and control groups. The site randomly selects 11 blocks from all possible six-block forms to include all the patients, Blinding description: In this study, the DUE unit expert only has complete information about the type of drug received (placebo or nanocurcumin supplement). This person plays no role in the administration, treatment evaluation, and data analysis. According to the codes, the patients who fulfill the inclusion criteria are randomly assigned to one of the groups by the DUE unit expert. The pills are then given to the researchers who are unaware of the content of the codes and the tablets type and then prescribed. The placebo pill is very similar to the nanocurcumin pill and contains the same ingredients except for the active ingredient. Therefore, patients and clinical caregivers can't distinguish pills from each other. 2-3 heart failure reduced EF. Intervention 1: Intervention group: 30 patients with HErEF which are admitted with congestion and decompensated symptoms will receive 40 mg nanocurcumin capsule twice a day for 7 days and standard therapy will be continued. Intervention 2: Control group: 30 patients with HErEF which are admitted with congestion and decompensated symptoms will receive 40 mg placebo capsule similar to original drug twice a day for 7 days and standard therapy will be continued. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I have not decided yet
public Emadoddin Hosseinjani
9th Boostan, Pasdaran St. Tehran,shahid Labbafinezhad Hospital
Tehran Iran (Islamic Republic of) 1666663111 +98 21 2360 2280 e.hosseinjani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Emadoddin Hosseinjani
9th Boostan, Pasdaran St. Tehran,shahid Labbafinezhad Hospital
Tehran Iran (Islamic Republic of) 1666663111 +98 21 2360 2280 e.hosseinjani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with reduced EF heart failure Signing an informed consent form 20 years 80 years Both No history of rheumatologic disease No active infection No acute kidney injury I50.2 Systolic (congestive) heart failure Treatment - Drugs Treatment - Drugs Intervention group: 30 patients with HErEF which are admitted with congestion and decompensated symptoms will receive 40 mg nanocurcumin capsule twice a day for 7 days and standard therapy will be continued. Control group: 30 patients with HErEF which are admitted with congestion and decompensated symptoms will receive 40 mg placebo capsule similar to original drug twice a day for 7 days and standard therapy will be continued. Interleukin 6. Timepoint: At the beginning of the study and after receiving the last dose of nanocurcumin. Method of measurement: Laboratory tests. NT-proBNP. Timepoint: At the beginning of the study and after receiving the last dose of nanocurcumin. Method of measurement: Laboratory tests. Serum creatinine. Timepoint: At the beginning of the study and after receiving the last dose of nanocurcumin. Method of measurement: laboratory tests. WBC count. Timepoint: En At the beginning of the study and after receiving the last dose of nanocurcumin. Method of measurement: laboratory tests. ALT. Timepoint: At the beginning of the study and after receiving the last dose of nanocurcumin. Method of measurement: laboratory tests. AST. Timepoint: At the beginning of the study and after receiving the last dose of nanocurcumin. Method of measurement: laboratory tests. Bagheiat-allah University of Medical Sciences Approved 2022-09-05 Research Ethice Committee of Baqiyatallah University of Medical Sciences Sheikh Bahaie South Street, Mulla Sadra Street, Vanak Square, Tehran, IRAN. Tehran Tehran Iran (Islamic Republic of)