Efficacy and Safety of Tian Ma Bian Chun Zhi Gan Tablets in Mild to Moderate Vascular Dementia

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2022
The study will be a 36-week multicentre, double-blind, placebo-controlled phase Ⅱb trial in China. Total 360 participants aged 55-80 years will be randomized to Tian Ma Bian Chun Zhi Gan group (84mg per day) or to placebo group. The primary endpoint will be Vascular Dementia Assessment Scale-cognitive subscale and Clinical Dementia Rating-Sum of Boxes. Secondary outcomes included changes in Mini-Mental State Examination, Clock Drawing Test, Delayed Story Recall and Ability of Daily Living. Patients\' safety will be assessed by recording of adverse events, clinical examinations, electrocardiography and laboratory tests. The patients, caregivers, and investigators will be blinded to the treatment allocations.
Epistemonikos ID: 0be150fdafd5c5997e53e799596caef1d69a746d
First added on: May 13, 2024