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Study aim
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Determination of the effect of EGCG-rich green tea powder on some clinical, biochemical, inflammatory, anti-oxidant and cognitive parameters in patients with ischemic stroke in a triple-blind, placebo-controlled clinical trial.
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Design
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This study was randomized controlled trial triple blind with parallel control group.
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Settings and conduct
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Rafsanjan Aliebe Abitaleb Hospital
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Participants/Inclusion and exclusion criteria
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inclusion criteria:
1- Patients referred to hospital in the first day of the stroke.
2- Patients with 30 to 80 years old.
3. Patients have completed the consent form.
4. Patients with an ischemic stroke.
5. Patients with an ischemic stroke of supratentorial.
- Exiclusion criteria :
1- Patients with hemorrhagic stroke.
2. Patients with severe stroke. (NIHSS> 25)
3 Patients with an ischemic stroke of lacunar and inferatentorial type.
4. Patients taked tPA.
5. Patients who have secondary stroke due to autoimmune disorders such as lupus and autoimmune hemolytic anemia and other inflammatory diseases.
6- pregnant patients .
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Intervention groups
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Intervention group: patients will take EGCG-enriched green tea powder twice a day ( 120 milligrams) as well as routine drugs associated with ischemic disease.
Control group: patients will take placebo tablets (cellulose vegetables, magnesium stearates, silica or maltodextrine) and routine drugs associated with ischemic disease.
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Main outcome variables
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Clinical Index (NIHSS, MRS and Quality of Life);
BDNF Factor;
Biochemical Index (LDL, HDL, Total Cholesterol, Triglycerides, Blood Glucose and CBC);
Inflammatory and angiogenesis Index (TNF-α, IL-1β, IL -10, CRP, ESR, CXCL12, CCL2, CXCL9 and CXCL10);
antioxidant index (Total Antioxidant Capacity and ROS);
cognitive function (MMSE test, Montreal test, Aden Burke cognitive test and Lotte cognitive test)