vascular dementia
Conditions
Interventions
SaiLuoTong high dose group:3 pills of SaiLuoTong (180 mg) each time, twice daily, for 52 weeks
SaiLuoTong low dose group:2 pills of SaiLuoTong capsule (120 mg) plus one pill of placebo each time, twice daily, for 52 weeks
control group:During the double-blind, placebo-controlled study, take 3 pills of placebo each time, twice daily, for 26 weeks. During the open-label extension study, take 2 pills of SaiLuoTong plus 1
Sponsors
Xuan Wu Hospital of Capital Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged 40 years old or above, male and female; 2. Education=primary-school; 3. Dementia diagnosed according to Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria; 4. Probable VaD diagnosed by the National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche et l'Enseignement en Neurosciences(NINDS-AIREN) criteria; 5. Modified Hachinski ischemic scale(MHIS) total score=4; 6. Evidence of ischemic cerebrovascular disease on magnetic resonance imaging (MRI)and /or CT (corresponding with the imaging criteria of NINDS-AIREN); 7. Mild-to-moderate dementia defined by MMSE score between 10 and 26, CDR score between 1 and 2, both inclusive; 8. Modified Hachinski ischemic scale(MHIS) total score=4; 9. Hamilton depression scale (HAMD) total score=17; 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, 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(activated partial thromboplastin time) beyond the normal value more than 10 seconds, PT (prothrombin time) beyond the normal value more than 3 seconds; Cr(creatinine) more than 1.5 times the upper limit value; ALT(alanine aminotransferase), AST(aspartate aminotransferase), or ALP(alkaline phosphates), ?-GT(?-glutamyl transferasemore) than 2 times the upper limit of normal, TBiL(total bilirubin) more than 1.5 times the upper limit of normal; 4. Nutrition metabolic diseases and endocrine system lesions such as thyroid disease, parathyroid diseases, and deficiency of vitamins or other elements; 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; medications that may affect cognitive functioning such as donepezil, rivastigmine, huperzine A, memantine, nimodipine; etc; 10. Known to be allergic to the composition of SaiLuoTong; 11. Pregnancy or breast-feeding women; 12. New strokes within 3 months before baseline; 13. Had participated in other clinical trials before this study 3 months prior to this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| V-ADAS-cog;ADCS-CGIC; | — |
Secondary
| Measure | Time frame |
|---|---|
| ADCS-ADL;MMSE;CDR;CDR-sb;CLOX;EXIT25;NP; | — |
Countries
China
Contacts
Public ContactJia Jianping
Xuan Wu Hospital of Capital Medical University
Outcome results
None listed