Vascular dementia(VaD)
Conditions
Interventions
high dose group of SaiLuoTong capsule:high dose of SaiLuoTong capsule
low dose group of SaiLuoTong capsule:low doses of SaiLuoTong capsule
the control group:placebo+low or high doses of SaiLuoTong capsule
Sponsors
Xuan Wu Hospital of Capital Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. >/=40 years old, gender is not limited; 2. Education>/=primary-school; 3. Dementia diagnosed according to DSM-IV(Diagnostic and Statistical Manual of Mental Disorders-4th Edition, DSM-IV) criteria; 4. VaD diagnosed by the National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche et l'Enseignement en eurosciences(NINDS-AIREN) criteria; 5. Modified Hachinski ischemic scale(MHIS) total score>/=4; 6. Evidence of ischemic cerebrovascular disease on MRI and / or CT, corresponding with the imaging diagnosed criteria of NINDS-AIRENMRI; 7. Mild to moderate VaD: MMSE from 10 to 26 and CDR from 1 to 2; 8. Hamilton depression scale (HAMD) total score </=17; 9. Qi deficiency and blood stasis of VaD diagnosed by Traditional Chinese Medicine; 10. The patients agree to participate in the study and able to understand informed consent as well as signing it. In cases where patients are unable to do so, legal carer's consent will be obtained as proxy; 11. There are carers accompanying patients at least 4 days a week and can accompany patients to participate in each visit.
Exclusion criteria
Exclusion criteria: 1.Dementia caused by other brain diseases except VaD (e.g. Alzheimer's disease,Lewy body dementia, frontotemporal dementia,Parkinson's disease, demyelinated disease of the central nervous system, tumour, hydrocephalus, head injury, central nervous system infection including syphilis, acquired immune deficiency syndrome,Creutzfeld-Jakob disease etc.); 2.The patient who can not complete examination because of severe brain or nerve function loss, such as convenient hand hemiplegia, all sorts of aphasia and audio-visual obstacles, etc; 3.The presence of abnormal laboratory parameters: Hb and Plt less than the lower limit; APTT beyond the normal value more than 10 seconds, PT beyond the normal value more than 3 seconds; Cr more than 1.5 times the upper limit value; ALT, AST, or ALP, gama-GT more than 2 times the upper limit of normal, TBiL more than 1.5 times the upper limit of normal; 4.Nutrition metabolic diseases and endocrine system lesions such as thyroid disease, parathyroid diseases; 5.Severe circulatory, respiratory, urinary, digestive, hematopoietic system diseases (such as unstable angina, incontrollable asthma, active bleeding, etc.) and cancer; 6.Severe mental illness (such as depression, schizophrenia) and epilepsy; 7.Gastrointestinal disorders that affect drug absorption, distribution, and metabolism; 8.Alcohol and drug abuse; 9.Patients who are using and cannot stop the following drugs including Chinese herba preparation containing ginseng, ginkgo leaf or any component of the saffron; Western medicine preparations such as donepezil, rivastigmine, huperzine A, memantine, and nimodipine; 10.Known to be allergic to the composition of SaiLuoTong; 11.Pregnancy or breast-feeding women; 12.Had participated in other clinical trials 3 months prior to this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VaDAS-cog;ADCS-CGI; | — |
Secondary
| Measure | Time frame |
|---|---|
| ADCS-ADL;MMSE;CDR-SB;CLOX;C-EXIT25;NPI;SPEC; | — |
Countries
China
Contacts
Public ContactJia Jianping
Xuanwu Hospital, Capital Medical University
Outcome results
None listed