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IRCT20140221016666N4 IRCT 2020-11-30 Mazandaran University of Medical Sciences Efficacy and safety of nano-curcumin on the clinical condition of patients with hemorrhagic stroke Efficacy and Safety of nano-curcumin on the clinical condition of patients with hemorrhagic stroke: A randomized, assessor-blind, parallel-group pilot study 2021-01-04 anticipated 40 Complete https://irct.ir/trial/51882 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random sample selection is based on block balance randomization with 4 blocks. The intervention and control groups are named A and B so that from the four blocks that will be shown in 6 states (AABB, BBAA, ABAB, BABA, ABBA, BAAB and using the table of random numbers, the row of blocks will be selected, Blinding description: The physician evaluating the patient will be blind. In this study, the physician who gives the medicine to the patients and the patients or participants are not blind and know the type of treatment but the assessors who examine patients and complete the questionnaire are blind and do not know the type of treatment. 3 Intracerebral hemorrhage. Intervention 1: Intervention group: Nano-curcumin medication with dosage of 80 mg for 12 weeks. Intervention 2: Control group: Patients with cerebral hemorrhage without medication. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Access period starts 6 months after the results are published To whom: It will be available only to researchers working in academic and scientific institutions Conditions: At the request of a scientific and academic reference Where to obtain: Narges Karimi, Drkarimi_236@yahoo.com How to obtain: By accepting the University Ethics Committee, data can be provided Comments:
public Narges Karimi
Mirjani street, Bagh Sang, Sari City
Sari Iran (Islamic Republic of) 4818734619 +98 11 3311 6275 drkarimi_236@yahoo.com Mazandaran University of Medical Sciences scientific Narges Karimi
Mirjani street, Bagh Sang, Sari city
Sari Iran (Islamic Republic of) 4818734619 +98 11 3311 6275 drkarimi_236@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Age 18-80 years, Diagnosis of ICH by brain CT scan, NIHSS> 4 and MRS <2 presymptomatic, bleeding in the putamen area, Glasgow criterion (GCS greater than 8) informed consent of the patient or first-degree relatives. 18 years 80 years Both Allergy to turmeric, pregnancy, liver disease with liver enzyme more than three times of normal range kidney disease or creatine more than 2, candidate for surgery and hematoma evacuation, secondary ICH for anticoagulant use and tumor and aneurysm and AVM, infratentorial hemorrhage, platelet count / 75,000 mm3 <, INR <1.4, fever at initial visit, other inflammatory diseases including pneumonia, hematology, rheumatology, urinary tract infection on admission. Immune suppressant drugs,] absorption syndromes, history of diabetes, smoking, alcohol and drug use I61 Nontraumatic intracerebral hemorrhage Treatment - Drugs Treatment - Drugs Intervention group: Nano-curcumin medication with dosage of 80 mg for 12 weeks Control group: Patients with cerebral hemorrhage without medication Improvement of the patient's disability and dysfunction to achieve MRS is below 3. Timepoint: At the time of admission, 24, 48 and 72 hours, 1 week (or last day of hospitalization), 4 weeks and 12 weeks. Method of measurement: MRS questionnaire. Reduce NIHSS to less than the initial 50% and reduce hematoma volume and increase Glasgow score. Timepoint: At the time of admission, 24, 48 and 72 hours, 1 week (or last day of hospitalization), 4 weeks and 12 weeks. Method of measurement: Hematoma size is measured using the formula ABC / 2 (A: The largest diameter in the largest bleeding slice, B the diameter perpendicular to A and C, the approximate number of 10 mm slices in which bleeding occurs). NIHSS Questionnaire and Glasgow scale. Mazandaran University of Medical Sciences Approved 2020-10-11 Ethics committee of Mazandaran University of Medical Sciences Moalem squre, Sari City Sari Mazandaran Iran (Islamic Republic of)