The purpose of the study is to determine weather Ginkgo biloba standardized extract (24% ginkoflavonoglicozides and 6% terpenes) is effective in treatment of cognitive and concentration impairment
Inclusion criteria is cerebrovascular insufficiency MNSE\>20. 90 patients are divided into three groups randomly. First group is being administered 120 mg ginkgo biloba extract, second group 60 mg of the extract and the third group has being administered placebo during the period of 6 months. Methods used for evaluation are SCAG, MMSE, MDRS, VFT, CGI, TCD and color Doppler of carotid arteries. Methods used for follow up safety include: routine blood tests, biochemical tests, neurologic and physical examination, vital signs and ECG.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
tablets, 120 mg/day (60 mg two times daily) during 6 months
tablets, 60 mg/day during 6 months
placebo during 6 months
University Department of Neurology, Sestre milosrdnice University Hospital, Vinogradska 29
Zagreb, Croatia
Changes of MDRS
Time frame: 6 months
Changes of VFT
Time frame: 6 months
Changes of CGI
Time frame: 6 months
Changes of SCAG
Time frame: 6 months
Changes of MMSE
Time frame: 6 months
Changes of TCD, and color Doppler of carotid arteries
Time frame: 6 months
Changes of platelets, hematocrit, prothrombin time, and activated partial tromboplastin time
Time frame: 6 months
Changes of total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides
Time frame: 6 months
Safety will be assessed according to occurrence of adverse events during the trial
Time frame: 6 months
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