Home › Research › Treatments
Efficacy and safety of Shenmayizhi decoction as an adjuvant treatment for vascular dementia: Study protocol for a randomized controlled trial
Wang H, Liu N, Wei Y, Pei H, Liu M, Diao X, Zhang H, Li H.. Medicine, 2019-12-01
Topic: Risk, prevention and care in population studies
Background Vascular dementia (VaD) is the second most common cause of dementia. The treatment of VaD still remains a challenge so far. Traditional Chinese Herbal medicine is a promising therapy due to their multiple components and targets. Shenmayizhi decoction (SMYZD), a Chinese Herbal prescription, has been reported its effective in alleviating cognitive dysfunction in clinical practice. However, strong clinical research of SMYZD in the treatment of VaD was lack. Therefore, we design this study to evaluate the adjuvant role of SMYZD in the treatment of VaD. Methods This is a multicenter, randomized, blind, controlled trial. A total of 196 eligible patients will be assigned to receive Ginkgo biloba extracts (GBEs) plus SMYZD granule or GBEs plus SMYZD mimetic granule in a 1:1 ratio. The duration of the trial will be 12 weeks, and a follow-up will be performed at the 24th week. The primary outcomes are the National Institute of Health stroke scale (NIHSS) and the Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog). The secondary outcomes include the Mini-Mental State Examination (MMSE), the traditional Chinese Medicine (TCM) syndrome scale, Activities of Daily Living (ADL), concentrations of hypersensitive C-reactive protein (Hs-CRP), neuron-specific enolase (NSE) and homocysteine (HCY) in serum. Researchers will record any adverse events throughout the trial. Discussion This study will provide evidences to evaluate the efficacy and safety of SMYZD in combination with GBEs in treatment of VaD, as well as the adjuvant role of SMYZD in combination. Trial is registered at chinese clinical trial registry ChiCTR1800017359.
Key findings
- The primary outcomes are the National Institute of Health stroke scale (NIHSS) and the Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog).
- The secondary outcomes include the Mini-Mental State Examination (MMSE), the traditional Chinese Medicine (TCM) syndrome scale, Activities of Daily Living (ADL), concentrations of hypersensitive C-reactive protein (Hs-CRP), neuron-specific enolase (NSE) and homocysteine (HCY) in serum.
- Researchers will record any adverse events throughout the trial.
- Discussion This study will provide evidences to evaluate the efficacy and safety of SMYZD in combination with GBEs in treatment of VaD, as well as the adjuvant role of SMYZD in combination.
- Trial is registered at chinese clinical trial registry ChiCTR1800017359.
Why it matters
This is a study protocol, so no results are available yet on whether Shenmayizhi decoction helps vascular dementia. The trial will compare it as an add-on to Ginkgo biloba extracts in 196 patients over 12 weeks.
New to this subject? Start with our plain-English guide: Treatments →
Study details
- Participants196
- Evidence strengthHigh
How this study scored 43/100
Published in a peer-reviewed journal. Scored zero for study design and effect reported because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Medicine) |
| Journal's citation record | 3 / 4 | Medicine: journal h-index 285 (OpenAlex, 2026-10-29) |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 2 / 5 | 2019 — within 10 year(s) of the newest study here |
| Sample size | 2 / 4 | 196 participants |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 1 / 2 | Randomised (as stated in the record) |
| Times cited | 2 / 7 | Cited 5 times (OpenAlex, 2026-10-10) |
| Citations per year | 0 / 5 | 0.6 citations a year over 9 year(s) since 2019 |
| Impact for its field and year | 1 / 6 | Cited 0.2× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 0 / 6 | No other study in this library cites it |
| Still being cited | 0 / 4 | Cited 2 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 2 / 4 | Last-listed author Hao Li: h-index 38 (OpenAlex, whole career) |
| Institution's track record | 0 / 3 | China Academy of Chinese Medical Sciences: institution h-index 304 (OpenAlex) |
| Multi-centre collaboration | 1 / 3 | OpenAlex lists 3 institution(s) in 1 country |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 31852125) |
| Free to read | 2 / 2 | Free to read |
| Total | 43 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
Full text: free to read — OpenAlex lists this copy as free to read: the link above (checked 6 Feb 1020).
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. The record names 8 authors; APA and Vancouver show the first six, BibTeX and the downloads carry all of them. Check the citation against the original before you use it.
APA 7th
Wang, H., Liu, N., Wei, Y., Pei, H., Liu, M., Diao, X., et al. (2019). Efficacy and safety of Shenmayizhi decoction as an adjuvant treatment for vascular dementia: Study protocol for a randomized controlled trial. Medicine. https://doi.org/10.1097/md.0000000000018326
Vancouver
Wang H, Liu N, Wei Y, Pei H, Liu M, Diao X, et al. Efficacy and safety of Shenmayizhi decoction as an adjuvant treatment for vascular dementia: Study protocol for a randomized controlled trial. Medicine. 2019. doi:10.1097/md.0000000000018326. PMID: 31852125.
BibTeX
@article{wang2019-31852125,
author = {Wang, H. and Liu, N. and Wei, Y. and Pei, H. and Liu, M. and Diao, X. and Zhang, H. and Li, H.},
title = {{Efficacy and safety of Shenmayizhi decoction as an adjuvant treatment for vascular dementia: Study protocol for a randomized controlled trial}},
journal = {Medicine},
year = {2019},
doi = {10.1097/md.0000000000018326},
pmid = {31852125},
url = {https://doi.org/10.1097/md.0000000000018326}
}
Studies this one cites
Referenced by this study and also in the alzhub library, so you can read them here.
Related studies in Treatments
Also tagged “double-blind”
783 studies in the library carry the topic tag “double-blind”; these are this study's neighbours in a fixed, alphabetical-by-hash tour of them, not the closest in content. All 783 tagged studies.