Evaluation of the effectiveness of Trigonella foenum graecum seed extract on the hs-CRP level in patients with myocardial infarction
Design
Phase 2 randomized double-blinded placebo parallel clinical trial on 60 patients Randomization using Randomaization.com
Settings and conduct
This study will perform in the heart ward of Ghaem Hospital in Mashhad. Patients are randomly assigned to Trigonella foenum graecum seed extract and placebo groups. Patients and the main researcher are unaware of groups assignation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with myocardial infarction based on the American Heart Association criteria; Consent to admission to the study; Age over 18 years; No kidney failure under hemodialysis; No severe liver failure with liver enzymes more than 3 times normal; No history of allergy to Trigonella foenum graecum or peas; No history of using medicinal products containing Trigonella foenum graecum seed extract
Exclusion criteria: Lack of consent to continue the study
Intervention groups
Patients with myocardial infarction receiving ٍTrigonella foenum graecum seed extract twice a day for one month along with common treatments
Main outcome variables
Changes in the hs-CRP levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220516054874N9
Registration date:2023-07-06, 1402/04/15
Registration timing:prospective
Last update:2023-07-06, 1402/04/15
Update count:0
Registration date
2023-07-06, 1402/04/15
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
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2025-07-23, 1404/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of Trigonella foenum graecum seed extract on the hs-CRP level in patients with myocardial infarction
Public title
Evaluation of the effects of Trigonella foenum graecum seed extract on patients with myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with myocardial infarction according to the American College of Heart criteria
Consent to admission to the study
Age more than 18 years old
Exclusion criteria:
Kidney failure under hemodialysis
Severe liver failure with liver enzymes three times more than normal
History of allergy to Trigonella foenum graecum or peas
History of using medicinal products containing Trigonella foenum graecum seed extract
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
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 blocks is written and numbers assigned to them, for example (AABB(1)- BBAA(2)- BABA(3)- BAAB(4)), which will be 15 blocks according to the sample size of 60. Then random numbers between 1 and 15 are selected according to the randomization site Randomaization.com and finally, the treatment allocation list is determined based on the random numbers.
Blinding (investigator's opinion)
Triple blinded
Blinding description
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
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
Changes in hs-CRP serum level
Timepoint
At the beginning of the study and after 4 weeks of treatment
Method of measurement
Laboratory kit
Secondary outcomes
1
Description
Changes in CBC diff
Timepoint
At the beginning of the study and after 4 weeks of treatment
Method of measurement
Laboratory kit
2
Description
Changes in lipid profile
Timepoint
At the beginning of the study and after 4 weeks of treatment
Method of measurement
Laboratory kit
Intervention groups
1
Description
Intervention group: Patients with myocardial infarction receiving Trigonella foenum graecum seed extract (335 mg, prepared by Barij essence company) twice a day for one month along with standard treatment
Category
Treatment - Drugs
2
Description
Control group: Patients with myocardial infarction receiving placebo tablet with the same shape and size twice a day for one month along with standard treatment
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital in Mashhad
Full name of responsible person
Dr. Bahram Shahri
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3801 2739
Email
ShahriB@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayour-Mobarhan
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. 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 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)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing 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