The effect of nanocurcumin on IL-6 and NT-proBNP reduction in patients with heart failure reduced EF
Design
It is a double-blind clinical trial, phase 3, with a placebo, performed on 60 patients with reduced EF heart failure. The permutation block method will be used for the randomization and patient allocation.
Settings and conduct
Heart Department of Baqiyatallah Hospital
Participants/Inclusion and exclusion criteria
patients with heart failure with reduced EF; no history of the rheumatologic disease; no active infection; no acute kidney injury
Signing an informed consent form.
Intervention groups
30 patients in the intervention group will receive a nanocurcumin supplement at a dose of 40mg twice daily with an standard regimen. 30 patients in the control group will receive a placebo twice a day with an standard regimen.
Main outcome variables
Interleukin 6; NT-ProBNP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221007056110N1
Registration date:2022-10-25, 1401/08/03
Registration timing:registered_while_recruiting
Last update:2022-10-25, 1401/08/03
Update count:0
Registration date
2022-10-25, 1401/08/03
Registrant information
Name
Emadoddin Hosseinjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 23601
Email address
e.hosseinjani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect and safety of nanocurcumin on patients with heart failure reduced EF (HFrEF)
Public title
Effect of nanocurcumin in heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with reduced EF heart failure
Signing an informed consent form
Exclusion criteria:
No history of rheumatologic disease
No active infection
No acute kidney injury
Age
From 20 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethice Committee of Baqiyatallah University of Medical Sciences
At the beginning of the study and after receiving the last dose of nanocurcumin
Method of measurement
Laboratory tests
2
Description
NT-proBNP
Timepoint
At the beginning of the study and after receiving the last dose of nanocurcumin
Method of measurement
Laboratory tests
Secondary outcomes
1
Description
serum creatinine
Timepoint
At the beginning of the study and after receiving the last dose of nanocurcumin
Method of measurement
laboratory tests
2
Description
WBC count
Timepoint
En At the beginning of the study and after receiving the last dose of nanocurcumin
Method of measurement
laboratory tests
3
Description
ALT
Timepoint
At the beginning of the study and after receiving the last dose of nanocurcumin
Method of measurement
laboratory tests
4
Description
AST
Timepoint
At the beginning of the study and after receiving the last dose of nanocurcumin
Method of measurement
laboratory tests
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah hospital
Full name of responsible person
Emadoddin Hosseinjani
Street address
Vanak Square, Mulla Sadra Street, after Sheikh Bahayi, Baqiyatallah
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 81261
Email
pr@bmsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Deputy of Research and Technology
Street address
Venk Square, Mulla Sadra St., Sheikh Bahai St., Baqiyatullah University, 3rd Floor, Research and Technology Vice-Chancellor
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5250
Email
R.bmsu@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Emadoddin Hosseinjani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
9th Boostan, Pasdaran St. Tehran,shahid Labbafinezhad Hospital
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2360 2280
Email
e.hosseinjani@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Emadoddin Hosseinjani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
9th Boostan, Pasdaran St. Tehran,shahid Labbafinezhad Hospital
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2360 2280
Email
e.hosseinjani@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Emadoddin Hosseinjani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
9th Boostan, Pasdaran St. Tehran,shahid Labbafinezhad Hospital
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2360 2280
Email
e.hosseinjani@sbmu.ac.ir
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