Efficacy and Safety of Butylphthalide Soft Capsule for the Treatment of Vascular Dementia

Exclusion Criteria

• •1\. Patients suffering from dementia caused by other cerebral diseases other than VaD (such as Alzheimer's disease, dementia with Lewy bodies, frontotemporal dementia, Parkinson's disease, demyelinating diseases of the central nervous system, tumors, hydrocephalus, traumas, syphilis, AIDS, Creutzfeldt-Jakob disease, etc.);
• •2\. MRI indicates hippocampus or entorhinal cortex atrophy; and patients for whom VaD in combination with AD has been maximally excluded. But the following two cases can be included: ① Those aged 70 years and above with MTA score of grade 2 can be included; ② Those with grade 3 white matter injury score can be included with MTA score of grade 2.
• •3\. Patients with severe neurologic impairments that hinder them from completing the required tests, such as hemiplegia of the convenient hand, various kinds of aphasia, and audio or visual disorders.
• •4\. Patients who cannot swallow any orally administered drugs, or who is suffering from any disease that can affect the absorption of orally administered drugs, such as active intestinal diseases, partial or complete intestinal obstruction.
• •5\. Patients suffering from severe diseases of the circulation system, the respiration system, the urinary system, the digestive system and the hemopoietic system (such as unstable angina pectoris, uncontrollable asthma and active gastric bleeding) and cancer.
• •6\. Patients suffering from nutritional and metabolic diseases and endocrine system disorders, such as thyroid disease, parathyroid disease and deficiency of vitamin or other elements.
• •7\. Patients suffering from severe mental diseases (such as depression and schizophrenia) and epilepsy.
• •8\. Patients with alcohol or drug abuse.
• •9\. Patients with a family history of dementia.
• •10\. Patients who have been given any drug that can affect the cognitive function, such as cholinergic drugs, antipsychotic drugs and nootropic agents (including traditional Chinese herbal medicines and pills, such as cholinesterase inhibitors, memantine, Cenma Yizhi Capsules and Jiannaoan), for a long period of time (within 3 month before the start of this study and will continue using such drug).
• •11\. Patients who have used Butylphthalide soft capsule or injection within 2 weeks before grouping.
• •12\. Patients who are allergic to Butylphthalide/celery.
• •13\. Patients with severe bleeding tendency or hepatic dysfunction (with transaminase higher than 3 times of the normal upper limit).
• •14\. Pregnant or breast feeding women.
• •15\. Patients who have participated in other interference clinical studies within 3 months before grouping.
• •16\. Patients for whom MRI cranial imaging cannot be performed.