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Tongxinluo capsule in the treatment of cerebral small vessel disease: protocol of a randomised, double-blind, placebo-controlled, multicentre clinical study (TOPS-CSVD)
Yingzhe Wang, Xiaodi Xie, Jun Liang Xu, Peng Lei, Kai Wang, Junjian Zhang, Jintai Yu, Mei Cui et al.. Stroke and Vascular Neurology, 2025-09-10
Topic: Brain proteins, microglia and lab models
The primary outcome of this clinical trial is the change in the Vascular Dementia Assessment Scale-cognitive subscale from baseline to 12 months. The primary safety outcome focuses on the incidence of adverse vital signs, including abnormalities in body temperature, heart rate, respiration and blood pressure. This trial has the potential to offer novel insights into the management of cognitive decline associated with CSVD through the application of traditional Chinese medicine. TRIAL REGISTRATION NUMBER: NCT06061692.
Key findings
- The primary outcome of this clinical trial is the change in the Vascular Dementia Assessment Scale-cognitive subscale from baseline to 12 months.
- The primary safety outcome focuses on the incidence of adverse vital signs, including abnormalities in body temperature, heart rate, respiration and blood pressure.
- This trial has the potential to offer novel insights into the management of cognitive decline associated with CSVD through the application of traditional Chinese medicine.
Why it matters
This is a protocol for a randomized, double-blind, placebo-controlled trial testing Tongxinluo capsule in cerebral small vessel disease, with the primary outcome being change in a vascular dementia cognitive scale at 12 months. No results are available yet, so it cannot yet show whether this traditional Chinese medicine affects cognitive decline.
Study details
- Participants1,052
- Evidence strengthHigh
How this study scored 48/100
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 (Stroke and Vascular Neurology) |
| Journal's citation record | 0 / 4 | Stroke and Vascular Neurology: journal h-index 61 (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 | 4 / 5 | 2025 — within 3 year(s) of the newest study here |
| Sample size | 3 / 4 | 1,052 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 | 2 / 2 | Randomised and blinded or placebo-controlled (as stated in the record) |
| Times cited | 1 / 7 | Cited 2 times (OpenAlex, 2026-10-10) |
| Citations per year | 0 / 5 | 0.7 citations a year over 3 year(s) since 2025 |
| Impact for its field and year | 1 / 6 | Cited 0.6× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 1 / 6 | Cited by 1 other studies in this library |
| Still being cited | 0 / 4 | Cited 2 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 3 / 4 | Last-listed author Qiang Dong: h-index 64 (OpenAlex, whole career) |
| Institution's track record | 1 / 3 | Fudan University: institution h-index 954 (OpenAlex) |
| Multi-centre collaboration | 3 / 3 | OpenAlex lists 13 institution(s) in 1 country |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 40935402) |
| Free to read | 2 / 2 | Free to read |
| Total | 48 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
- DOI: 10.1136/svn-2024-003929
- PubMed: 40935402
- Original source →
- Free full text: Stroke and Vascular Neurology →
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's author list ends in “et al.”, so not every author is named. Check the citation against the original before you use it.
APA 7th
Wang, Y., Xie, X., Xu, J. L., Lei, P., Wang, K., Zhang, J., et al. (2025). Tongxinluo capsule in the treatment of cerebral small vessel disease: protocol of a randomised, double-blind, placebo-controlled, multicentre clinical study (TOPS-CSVD). Stroke and Vascular Neurology. https://doi.org/10.1136/svn-2024-003929
Vancouver
Wang Y, Xie X, Xu JL, Lei P, Wang K, Zhang J, et al. Tongxinluo capsule in the treatment of cerebral small vessel disease: protocol of a randomised, double-blind, placebo-controlled, multicentre clinical study (TOPS-CSVD). Stroke and Vascular Neurology. 2025. doi:10.1136/svn-2024-003929. PMID: 40935402.
BibTeX
@article{wang2025-40935402,
author = {Wang, Yingzhe and Xie, Xiaodi and Xu, Jun Liang and Lei, Peng and Wang, Kai and Zhang, Junjian and Yu, Jintai and Cui, Mei and others},
title = {{Tongxinluo capsule in the treatment of cerebral small vessel disease: protocol of a randomised, double-blind, placebo-controlled, multicentre clinical study (TOPS-CSVD)}},
journal = {Stroke and Vascular Neurology},
year = {2025},
doi = {10.1136/svn-2024-003929},
pmid = {40935402},
url = {https://doi.org/10.1136/svn-2024-003929}
}
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