Evaluation of the effectiveness of Portulaca oleracea L. seed extract on the hs-CRP level in patients with non ST-elevation myocardial infarction
Design
Phase 2 randomized double-blinded placebo parallel clinical trial on 80 patients Randomization using Randomaization.com
Settings and conduct
This study will perform in the heart ward and clinic of Imam Reza Hospital in Mashhad. Patients are randomly assigned to Portulaca oleracea L. seed extract and placebo groups. Patients and the main researcher are unaware of groups assignation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with non-ST-elevation MI based on the American Heart Association criteria; Consent to admission to the study; Age over 18 years; No kidney failure under hemodialysis; No kidney failure and GFR<30; No thrombocytopenia; No severe liver failure with liver enzymes more than 3 times normal; No treatment with corticosteroids or immunosuppressive drugs; No treatment with diltiazem or verapamil
Exclusion criteria: Lack of consent to continue the study
Intervention groups
Intervention group: Patients with non-ST-elevation MI receiving Portulaca oleracea L. seed extract 600 mg twice daily after meal for one month along with common treatments Placebo group: Patients with non-ST-elevation MI receiving a placebo capsule twice daily for one month along with common treatments
Main outcome variables
Primary outcome: Changes in the hs-CRP levels at the beginning of the study and after 4 weeks of treatment.
Secondary outcome: Changes in the level of CBC diff., lipid profile, and IL-6 at the beginning of the study and after 4 weeks of treatment.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220516054874N3
Registration date:2022-07-17, 1401/04/26
Registration timing:prospective
Last update:2022-07-17, 1401/04/26
Update count:1
Registration date
2022-07-17, 1401/04/26
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
2022-07-23, 1401/05/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Portulaca oleracea L. seed extract on the hs CRP level in patients with non ST-elevation myocardial infarction
Public title
Evaluation of the effect of Portulaca oleracea L. seed extract in patients with myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with non-ST-elevation MI according to the American College of Heart criteria
Consent to admission to the study
Age more than 18 years old
No kidney failure under hemodialysis
No kidney failure and GFR<30
No thrombocytopenia
No severe liver failure with liver enzymes three times more than normal
No treatment with corticosteroids or immunosuppressive drugs
No treatment with diltiazem or verapamil
Exclusion criteria:
Lack of consent to continue the study
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
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 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.
Blinding (investigator's opinion)
Double 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
Ethic's committee of Mashhad University of Medical Sciences
Street address
Qurashi Building, Next to Hoveyzeh Cinema, University Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2022-05-17, 1401/02/27
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.131
Health conditions studied
1
Description of health condition studied
Myocardial infarction with non-ST elevation
ICD-10 code
I21.4
ICD-10 code description
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
3
Description
Changes in Interleukin-6 level
Timepoint
At the beginning of the study and after 4 weeks of treatment
Method of measurement
Laboratory kit
Intervention groups
1
Description
Intervention group: NSTEMI patients receiving Portulaca oleracea L. seed extract 300 mg twice daily for one month along with standard treatment
Category
Treatment - Drugs
2
Description
Control group: NSTEMI patients receiving placebo capsule twice daily for one month along with standard treatment
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Cardiology, Imam Reza Hospital
Full name of responsible person
Dr. Arash Gholoobi
Street address
Imam Reza hospital, Ebnsina Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
gholoobia@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
baradaranrv@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)
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