The efficacy and safety of Fufangdanshen tablets (Radix Salviae miltiorrhizae formula tablets) for mild to moderate vascular dementia: a study protocol for a randomized controlled trial.
Vascular dementia (VaD) is the second most common subtype of dementia after Alzheimer's disease (AD). Currently, there are no medications approved for treating patients with VaD. Fufangdanshen (FFDS) tablets (Radix Salviae miltiorrhizae formula tablets) are a traditional Chinese medicine that has been reported to improve memory. However, the existing evidence for FFDS tablets in clinical practice derives from methodologically flawed studies. To further investigate the safety, tolerability, and efficacy of FFDS tables in the treatment of mild to moderate VaD, we designed and reported the methodology for a 24-week randomized, double-blind, parallel, multicenter study.



This ongoing study is a double-blind, randomized, parallel placebo-controlled trial. A total of 240 patients with mild to moderate VaD will be enrolled. After a 2-week run-in period, the eligible patients will be randomized to receive either three FFDS or placebo tablets three times per day for 24 weeks, with a follow-up 12 weeks after the last treatment. The primary efficacy measurement will be the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and the Clinician Interview-Based Impression of Change (CIBIC-plus). The secondary efficacy measurements will include the Mini Mental State Examination (MMSE) and activities of daily living (ADL). Adverse events will also be reported.



This randomized trial will be the first rigorous study on the efficacy and safety of FFDS tablets for treating cognitive symptoms in patients with VaD using a rational design.



ClinicalTrials.gov: NCT01761227 . Registered on 2 January 2013.
BUCM Neurology Centre, Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing, China. jztian@hotmail.com.
Jinzhou
J
Tian
BUCM Neurology Centre, Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing, China.
Jing
J
Shi
BUCM Neurology Centre, Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing, China.
Mingqing
M
Wei
Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited, Guangzhou, China.
Renan
R
Qin
BUCM Neurology Centre, Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing, China.
Jingnian
J
Ni
BUCM Neurology Centre, Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing, China.
Xuekai
X
Zhang
BUCM Neurology Centre, Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing, China.
Ting
T
Li
Institute of Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
Yongyan
Y
Wang
D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D002985:Clinical Protocols; D015140:Dementia, Vascular / Q000188:drug therapy*; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D013607:Tablets
D004365:Drugs, Chinese Herbal; D013607:Tablets; C517866:fufang danshen
Chinese medicine; Fufangdanshen tablets; Randomized controlled trial; Vascular dementia