Protocol summary
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Study aim
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Evaluation of the effectiveness of Portulaca oleracea L. seed extract on the hs-CRP level in patients with myocardial infarction
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Design
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Phase 2 randomized double-blinded placebo parallel clinical trial on 80 patients Randomization using Randomaization.com
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with 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
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Intervention groups
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Intervention group: Patients with MI receiving Portulaca oleracea L. seed extract 600 mg twice daily after meal for one month along with common treatments Placebo group: Patients with MI receiving a placebo capsule twice daily for one month along with common treatments
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Main outcome variables
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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
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Reason for update
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Due to the sampling conditions and the prolongation of the student's thesis, the sampling range was changed from patients with non-ST segment elevation myocardial infarction to patients with myocardial infarction.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220516054874N3
Registration date:
2022-07-17, 1401/04/26
Registration timing:
prospective
Last update:
2023-04-03, 1402/01/14
Update count:
1
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Registration date
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2022-07-17, 1401/04/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-04-04, 1402/01/15
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Expected recruitment end date
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2025-02-19, 1403/12/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the effectiveness of Portulaca oleracea L. seed extract on the hs CRP level in patients with myocardial infarction
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Public title
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Evaluation of the effect of Portulaca oleracea L. seed extract in patients with myocardial infarction
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with 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
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Age
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From 18 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Investigator
- Data analyser
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Sample size
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Target sample size:
68
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-05-17, 1401/02/27
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1401.131
Health conditions studied
1
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Description of health condition studied
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Myocardial infarction
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ICD-10 code
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I21
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ICD-10 code description
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ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
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Description
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Changes in hs-CRP serum level
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Timepoint
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At the beginning of the study and after 4 weeks of treatment
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Method of measurement
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Laboratory kit
Secondary outcomes
1
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Description
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Changes in CBC diff
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Timepoint
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At the beginning of the study and after 4 weeks of treatment
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Method of measurement
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Laboratory kit
2
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Description
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Changes in lipid profile
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Timepoint
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At the beginning of the study and after 4 weeks of treatment
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Method of measurement
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Laboratory kit
3
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Description
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Changes in Interleukin-6 level
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Timepoint
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At the beginning of the study and after 4 weeks of treatment
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Method of measurement
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Laboratory kit
Intervention groups
1
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Description
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Intervention group: MI patients receiving Portulaca oleracea L. seed extract 300 mg twice daily for one month along with standard treatment
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Category
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Treatment - Drugs
2
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Description
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Control group: MI patients receiving placebo capsule twice daily for one month along with standard treatment
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available