Investigating the effect of the rose hip alcoholic extract on echocardiographic parameters in patients with heart failure with reduced ejection fraction
Investigating the effect of the rose hip alcoholic extract on echocardiographic parameters in patients with heart failure with reduced ejection fraction
Design
Phase 3 randomized double-blinded placebo parallel clinical trial on 72 patients. Randomization using Randomaization.com
Settings and conduct
This study will be performed on heart failure patients with systolic dysfunction in the heart ward of Ghaem Hospital in Mashhad. Patients are randomly assigned to rose hip and placebo groups. Randomization will be done using a block method with a block size of 4. The blocked randomization method is used with the volume of each block of four. Sealed envelopes will be used to conceal allocation. A person not involved in sampling and data collection will prepare envelopes and randomize allocation. Due to the use of a placebo similar to the intervention treatment, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age older than 18 years old; Heart failure diagnosis with systolic dysfunction; Signed written informed consent to participate in the study.
Not-Inclusion criteria: New York Heart Association Class IV heart failure; Renal dysfunction with eGFR < 20; Hepatic dysfunction; Body mass index < 18.5 kg/m2; Use of warfarin, lithium, chemotherapy drugs; Pregnant or suspected pregnancy.
Intervention groups
Intervention group: Taking 250 mg Rose hip alcoholic extract tablets four times a day along with standard treatments.
Placebo group: Taking placebo tablets four times a day along with standard treatments.
Main outcome variables
Echocardiographic parameters including LVEF، LVESVI، LVEDVI، LVIDs، LVIDd، RWT، E/Em، ESV index, , LA volume index, LA strain, LV strain, PAP, LVOT VTI, RV diameter.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220516054874N18
Registration date:2024-07-14, 1403/04/24
Registration timing:prospective
Last update:2024-07-14, 1403/04/24
Update count:0
Registration date
2024-07-14, 1403/04/24
Registrant information
Name
Vafa Baradaran Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2301
Email address
baradaranrv@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2026-07-23, 1405/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of the rose hip alcoholic extract on echocardiographic parameters in patients with heart failure with reduced ejection fraction
Public title
The effect of the rose hip alcoholic extract on patients with heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age older than 18 years old
Heart failure diagnosis with systolic dysfunction
Signed written informed consent to participate in the study
Exclusion criteria:
New York Heart Association Class IV heart failure
Renal dysfunction with GFR < 20
Hepatic dysfunction
Body mass index < 18.5 kg/m2
Use of warfarin, lithium, chemotherapy drugs
Pregnant or suspected pregnancy
Other comorbidities including various infections, major surgery, type 1 diabetes, pituitary or adrenal insufficiency, cancer
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
The blocked randomization method is used.
The volume of each block will be four. Then, the list of possible blocks is written and numbers assigned to them, for example (AABB(1)- BBAA(2)- BABA(3)- BAAB(4)), which will be 17 blocks according to the sample size of 68. Then, random numbers between 1 and 17 are selected according to the randomization site Randomaization.com and finally, the treatment allocation list is determined based on the random numbers. Sealed envelopes will be used to conceal allocation. A person not involved in sampling and data collection will prepare envelopes and randomize allocation.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Blinding will performed using sealed envelopes. Due to the use of a placebo similar to the intervention treatment, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups. Finally, after analyzing the data, the researcher who prepared the packages will reveal the codes A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Imam Reza Hospital Educational, Research and Treatment Center, Mashhad
Echocardiography parameters including LVEF، LVESVI، LVEDVI، LVIDs، LVIDd, LA volume index, LA strain, LV strain, PAP, RV diameter.
Timepoint
The beginning of the study and one months later
Method of measurement
Echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Taking rose hip alcoholic extract 250 mg tablets four times a day for one month along with standard treatment.
Category
Treatment - Drugs
2
Description
Control group: Taking placebo tablets, which look exactly like 250 mg rose hip alcoholic extract tablet. Placebo will be prepared in the Pharmaceutics Laboratory of Mashhad School of Pharmacy and will be performed four times a day for one month along with standard treatments.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital in Mashhad
Full name of responsible person
Dr. Hedieh Alimi
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3801 2739
Email
alimih@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Qurashi Building, Next to Hoveyzeh Cinema, University Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
Ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vafa Baradaran Rahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
baradaranrv@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Hedieh Alimi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
alimih@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vafa Baradaran Rahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
baradaranrv@mums.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