Evaluation of the effect of curcumin-piperine supplement in patients with acute ischemic stroke

Phase 3

Conditions: Acute ischemic stroke.
Cerebral infarction due to cerebral venous thrombosis, nonpyogenic
I63.6

Registration Number: IRCT20201220049774N4

Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 68

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.