Condition 1: Ischemic stroke. Condition 2: The sequelae of Ischemic Stroke. Cerebral infarction due to thrombosis of cerebral arteries Sequelae of cerebral infarction
Conditions
Interventions
Intervention 1: Intervention group:
Lithium carbonate tablet 300 mg twice per day
in addition to standard treatment regimen of ASA 80 mg/day, Atorvastatin 20 mg/day and Folic acid 1mg/day and 10 sess
Treatment - Drugs
Placebo
Intervention group:
Lithium carbonate tablet 300 mg twice per day
in addition to standard treatment regimen of ASA 80 mg/day, Atorvastatin 20 mg/day and Folic acid 1mg/day and 10 sessions of physio
Control group:
Placebo tablet twice per day
in addition to standard treatmet regimen of ASA 80mg/day, Atorvastatin 20mg/day and Folic acid 1mg/day and 10 sessions of physiotherapy
Sponsors
Deputy of research, Ahvaz Jundishapur University of Medical Sciences
Eligibility
Sex/Gender
All
Age
50 Years to 90 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Age among 50 to 90; Sufferer from ischemic stroke (ischemic cerebrovascular accident) including class 1, 4 or 5 of TOAST classification system (i.e. all subtypes of ischemic stroke except than embolic stroke with cardiac origin) in the territory of middle cerebral artery; Maximum time passed from stroke should be equal or less than 48 hours; Consent for participation in study (by patient or his/her first degree relative); No-participation in any other clinical trial; Non-menopause females should not be pregnant or lactating mother. Exclusion criteria: Co-existence of intracerebral hemorrhage (subarachnoid or intraparenchymal) or hemorrhagic conversion during hospitalization; Severe loss of consciousness (score greater than 3 from 1b and 1c questions of NIHSS in the time of entering to the study); Wernicke aphasia (pure or as a part of constellation of other symptoms); Organ failures that may interfere with consumption of lithium, including: Acute or chronic kidney disease (Cr> 1.2) Acute or chronic heart failure (EF 9cm or history of orthopnea or nocturnal dyspnea) Acute myocardial infarction (during past 3 months or current hospitalization) Pulmonary edema Respiratory distress that demands ventilator Acute or chronic diarrhea that lead to significant dehydration (dryness of mucosal membrane, sunken eyes or Bun/Cr ratio >20) History of thyroid dysfunction or abnormal TSH Inevitable need to thiazide diuretics, potassium sparing diuretics or ACE inhibitors (but not ARB like Losartan) or calcium channel blockers or need to more than 80mg/day of furosemide); Inevitable need to NSAID except than Aspirin; Non-adherence to physiotherapy and ordered rehabilitation.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional outcome of stroke patients. Timepoint: in the 5th day of intervention and in the 30th day of intervention. Method of measurement: By using NIHSS and Barthel index score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mortality rate in stroke patients. Timepoint: During 30 days of intervention. Method of measurement: Based on the number of died cases. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Seyed Aidin Sajedi
Neurology ward of Golestan hospital
Outcome results
None listed