Efficacy and safety of nano-curcumin on the clinical condition of patients with hemorrhagic stroke

Phase 3

Recruiting

Conditions: Intracerebral hemorrhage.
Nontraumatic intracerebral hemorrhage

Registration Number: IRCT20140221016666N4

Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.