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Rationale and design of a multicenter, phase 2 clinical trial to investigate the efficacy of traditional Chinese medicine SaiLuoTong in vascular dementia
Liang J, Li F, Wei C, Song H, Wu L, Tang Y, Jia J.. Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association, 2014-10-05
Topic: Risk, prevention and care in population studies
Background Vascular dementia (VaD) is the second most prevalent type of dementia among the aged, for whom limited pharmacologic options are available so far. SaiLuoTong capsule is a modern traditional Chinese medicine formula, which has been demonstrated to improve cognition of VaD by the reports of animal experiments and preliminary clinical trial. However, evaluation of this therapy in randomized multicenter trials is needed. In this article, we present the rationale and design of the SaiLuoTong in Vascular Dementia Study. Methods This phase 2 clinical trial of SaiLuoTong among patients with mild-to-moderate VaD is a 26-week, multicenter, randomized, double-blind, placebo-controlled study with a subsequent 26-week, open-label extension. After a 4-week placebo run-in period, participants are centrally randomized (1:1:1) to 3 groups: group A receives SaiLuoTong 360 mg per day for 52 weeks; group B receives SaiLuoTong 240 mg per day for 52 weeks; group C (the control group) are further randomly assigned to 2 groups in a 1:1 ratio and receives placebo during the double-blind phase, then SaiLuoTong 360 mg per day or SaiLuoTong 240 mg per day during the extension phase. The primary outcome measures include the VaD assessment scale cognitive subscale and the Alzheimer Disease Cooperative Study-clinical global impression of change. Safety measures include body weight, vital signs, electrocardiography, laboratory tests, and records of adverse events. Assuming an attrition rate of 20%, at least 372 patients are required to obtain a statistical power of 80%. Results The first patient was enrolled into the study in April 2012 and the completion of the study is expected in September 2014. Conclusions The rigorous methodology of the study will hopefully move forward the scientific evaluation of traditional Chinese medicine in treatment of VaD. The results of the present study will provide high-quality evidence on the effect of SaiLuoTong in patients with VaD and has the potential to establish a novel therapeutic approach for this disorder.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Liang, J., Li, F., Wei, C., Song, H., Wu, L., Tang, Y., et al. (2014). Rationale and design of a multicenter, phase 2 clinical trial to investigate the efficacy of traditional Chinese medicine SaiLuoTong in vascular dementia. Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association. https://doi.org/10.1016/j.jstrokecerebrovasdis.2014.06.005
Vancouver
Liang J, Li F, Wei C, Song H, Wu L, Tang Y, et al. Rationale and design of a multicenter, phase 2 clinical trial to investigate the efficacy of traditional Chinese medicine SaiLuoTong in vascular dementia. Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association. 2014. doi:10.1016/j.jstrokecerebrovasdis.2014.06.005. PMID: 25294055.
BibTeX
@article{liang2014-25294055,
author = {Liang, J. and Li, F. and Wei, C. and Song, H. and Wu, L. and Tang, Y. and Jia, J.},
title = {{Rationale and design of a multicenter, phase 2 clinical trial to investigate the efficacy of traditional Chinese medicine SaiLuoTong in vascular dementia}},
journal = {Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association},
year = {2014},
doi = {10.1016/j.jstrokecerebrovasdis.2014.06.005},
pmid = {25294055},
url = {https://doi.org/10.1016/j.jstrokecerebrovasdis.2014.06.005}
}
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 7 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.
Key findings
- SaiLuoTong capsule is a modern traditional Chinese medicine formula, which has been demonstrated to improve cognition of VaD by the reports of animal experiments and preliminary clinical trial.
- Results The first patient was enrolled into the study in April 2012 and the completion of the study is expected in September 2014.
- The results of the present study will provide high-quality evidence on the effect of SaiLuoTong in patients with VaD and has the potential to establish a novel therapeutic approach for this disorder.
Why it matters
This is a design paper for a trial testing a traditional Chinese medicine in vascular dementia, a different condition from Alzheimer's disease. No results are reported, so it shows nothing about treating, curing or preventing Alzheimer's disease.
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Study details
- Study designclinical trial
- Participants372
- Evidence strengthHigh
How this study scored 53/100
Published in a peer-reviewed journal, and it is a randomised controlled trial. Scored zero for effect reported because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association) |
| Journal's citation record | 1 / 4 | Journal of Stroke and Cerebrovascular Diseases: journal h-index 104 (OpenAlex, 2026-10-29) |
| Study design | 11 / 12 | A randomised controlled trial (from PubMed type “Randomized Controlled Trial”) |
| 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 | 1 / 5 | 2014 — within 20 year(s) of the newest study here |
| Sample size | 2 / 4 | 372 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 | 2 / 7 | Cited 12 times (OpenAlex, 2026-10-10) |
| Citations per year | 0 / 5 | 0.9 citations a year over 14 year(s) since 2014 |
| Impact for its field and year | 2 / 6 | Cited 1.1× 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 1 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 3 / 4 | Last-listed author Jianping Jia: h-index 61 (OpenAlex, whole career) |
| Institution's track record | 0 / 3 | Capital Medical University: institution h-index 643 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | PubMed indexes it as a multicentre study |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 25294055) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Total | 53 / 100 | — |
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