Efficacy and Safety of Tianzhi Granule in Mild to Moderate Vascular Dementia

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This ongoing study aimed to evaluate the efficacy and safety of Tianzhi granule in mild to moderate vascular dementia in a more reasonable design.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dongzhimen Hospital, Beijing
• Treatments: Donepezil

Criteria

Inclusion Criteria:

• Inpatients and outpatients meeting the diagnostic criteria probable VaD established according to the Diagnostic and Statistical Manual of Mental Disorders (fourth edition) （DSM-Ⅳ） and the National Institute of Neurological Disorders and Stroke and the Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS-AIREN)were eligible to participate,

• diagnosis of mild to moderate vascular dementia;

• Chinese-speaking patients aged ≥45 and≤85 years old in both gender;

• weighing between 45 and 90kg;

• fully conscious;

• MMSE score of≤26 and ≥14;

• HIS score of ≥7;

• adequate vision and hearing ability to complete all study tests;

• with a stable caregiver.

Exclusion Criteria:

Patients will be excluded from the enrollment if they meet any of the followings:

• a medical history of other dementia types, like Alzheimer's disease, Parkinson's disease dementia, Huntington disease, Normal pressure hydrocephalus, et al;

• major depression (HAMD for 17 items>17) or psychotic disorder;

• acute stage of cerebral hemorrhage or subarachnoid hemorrhage;

• hypothyroidism;

• drug or alcohol abuse;

• epilepsy history; myasthenia gravis history;

• severe cardiovascular disease(severe arrhythmia with heart rate≥100 or≤60 times per min, left bundle branch block, myocardial infarction within 3 months, systolic pressure≥180mmHg or ≤90mmHg);

• severe liver or kidney dysfunction (alanine aminotransferase>60 IU/L, aspartate transaminase>60 IU/L or serum creatinine >266μmol/L);

• severe asthma or chronic obstructive pulmonary disease;

• gastrointestinal tract obstruction or severe peptic ulcer; glaucoma;

• administration of cholinesterase inhibitors, memantine or nimodipine in the last month;

• use of sympathomimetic agent, antihistamine drug, antianxiety drugs or tranquilizer within 48h before assessment;

• use of antipsychotic drugs within 72h before assessment;

• participation in other clinical trials; allergic history to any type of medication used in this study.