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IRCT20201220049774N4 IRCT 2022-11-18 Mashhad University of Medical Sciences Evaluation of the effect of curcumin-piperine supplement in patients with acute ischemic stroke Evaluation of the effect of curcumin-piperine supplement administration on the severity of injury and function in patients with acute ischemic stroke 2022-12-07 anticipated 68 Complete https://irct.ir/trial/66895 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Replacement blocks using the site https://www.sealedenvelope.com with the explanation that each of the blocks has 4 members and the shape of the blocks can be as follows, for example: [ABAB], [BBAA], [BABA], … Codes A and B are randomly assigned to intervention and control groups. The site mentioned above randomly selects 17 blocks out of all four possible blocks to include all patients in the study, Blinding description: In this study, only the DUE unit expert has full knowledge of the type of drug received (placebo or curcumin-piperine supplement) and this person has no role in prescribing, evaluating treatment, and analyzing data. Patients who meet the conditions for entering the study are randomly assigned to one of the groups by the aforementioned expert based on the set codes. Then the pills are placed in the hands of researchers who are unaware of the content of the codes and the type of pills, and they are prescribed. The placebo tablet looks completely similar to the curcumin-piperine tablet and contains the same ingredients except for the active ingredient. Therefore, it is not possible to distinguish pills from each other by patients and clinical caregivers. 3 Acute ischemic stroke. Intervention 1: Intervention group: 34 patients in the curcumin-piperine supplement group, as soon as possible after confirming the diagnosis of acute ischemic stroke, will receive curcumin-piperine tablets at a dose of 500/5 mg twice a day for 4 days along with standard treatment. Intervention 2: Control group: 34 patients in the control group will receive a placebo pill twice a day for 4 days along with a standard ischemic stroke treatment regimen. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I have not decided yet.
public Hesamoddin Hosseinjani
Department of Clinical Pharmacy, Faculty of Pharmacy, Ferdowsi University Campus, Azadi Square, Mashhad
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1586 hosseinjanih@mums.ac.ir Mashhad University of Medical Sciences scientific Hesamoddin Hosseinjani
Department of Clinical Pharmacy, Faculty of Pharmacy, Ferdowsi University Campus, Azadi Square, Mashhad
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1586 hosseinjanih@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 80 years Less than 24 hours have passed since the onset of stroke. The patient has been diagnosed with an acute ischemic stroke. GCS of the patient at the time of visit should be more than 13. The NIHSS range is between 5 and 20. MRS is less than 2 before the onset of stroke. Sign the informed consent form 50 years 80 years Both Patients receiving rtPA Candidate patients for endovascular treatment, mechanical thrombectomy or craniotomy Pregnancy or breastfeeding History of allergy to turmeric or black pepper Taking immunosuppressive drugs Concomitant receipt of any drug or supplement with an antioxidant or anti-inflammatory effect or an approved immune system regulator I63.6 Cerebral infarction due to cerebral venous thrombosis, nonpyogenic Treatment - Drugs Treatment - Drugs Intervention group: 34 patients in the curcumin-piperine supplement group, as soon as possible after confirming the diagnosis of acute ischemic stroke, will receive curcumin-piperine tablets at a dose of 500/5 mg twice a day for 4 days along with standard treatment. Control group: 34 patients in the control group will receive a placebo pill twice a day for 4 days along with a standard ischemic stroke treatment regimen. Assessment of stroke severity based on NIH Stroke Scale (NIHSS). Timepoint: Days 0 and 4 of study. Method of measurement: Questionnaire. Evaluation of patients' performance based on Modified Rankin Scale (MRS) and Barthel index (BI). Timepoint: Days 0, 4 and 30 of the study. Method of measurement: Questionnaire. Complete blood count with differential. Timepoint: Once at study entry and again after receiving the last dose of curcumin-piperine. Method of measurement: Laboratory tests. Total and direct bilirubin. Timepoint: Once at study entry and again after receiving the last dose of curcumin-piperine. Method of measurement: Laboratory tests. C-reactive protein (CRP). Timepoint: Once at study entry and again after receiving the last dose of curcumin-piperine. Method of measurement: Laboratory tests. Hemoglobin A1c (HbA1c). Timepoint: Once at study entry and again after receiving the last dose of curcumin-piperine. Method of measurement: Laboratory tests. Early death. Timepoint: One week and one month after starting the study. Method of measurement: Information about the patient's condition by phone call. Mashhad University of Medical Sciences Approved 2022-07-02 Research Ethics Committee of Mashhad University of Medical Sciences Department of Clinical Pharmacy, Faculty of Pharmacy, Ferdowsi University Campus, Azadi Square Mashhad Razavi Khorasan Iran (Islamic Republic of)