Evidence map›Paper›PMID 40935402›Full record

ArticleStroke and vascular neurology2026

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 Xu, Peng Lei, Kai Wang, Junjian Zhang, Jintai Yu, Mei Cui, Qiang Dong

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Stroke and vascular neurology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06061692 (Tongxinluo Capsule in the Treatment of Cerebral Small Vessel Disease-A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06061692 phase4not yet recruitingnot on this map

Tongxinluo Capsule in the Treatment of Cerebral Small Vessel Disease-A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study (TOPS-CSVD)

TypeinterventionalSponsorFudan UniversityRan2023 to 2026Enrolled1,052ConditionsCerebral Small Vessel DiseasesArmsTongxinluo Capsule
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Yingzhe Wang *Department of Neurology, Huashan Hospital Fudan University, Shanghai, China.ORCID http://orcid.org/0000-0002-8401-2644
Xiaodi Xie *Department of Neurology, Huashan Hospital Fudan University, Shanghai, China.
Jun XuBeijing Tiantan Hospital, Capital Medical University, Beijing, China.ORCID http://orcid.org/0000-0001-7432-6781
Peng LeiDepartment of Neurology, Sichuan University West China Hospital, Chengdu, Sichuan, China.
Kai WangDepartment of Neurology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.
Junjian ZhangDepartment of Neuropsychology, Zhongnan Hospital of Wuhan University, Wuhan, China.
Jintai YuDepartment of Neurology, Huashan Hospital Fudan University, Shanghai, China.ORCID http://orcid.org/0000-0002-7079-8041
Mei CuiDepartment of Neurology, Huashan Hospital Fudan University, Shanghai, China dong_qiang@fudan.edu.cn cuimei@fudan.edu.cn.ORCID http://orcid.org/0000-0002-6449-8106
Qiang DongDepartment of Neurology, Huashan Hospital Fudan University, Shanghai, China dong_qiang@fudan.edu.cn cuimei@fudan.edu.cn.ORCID http://orcid.org/0000-0002-3874-0130

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTongxinluo capsule has demonstrated multiple beneficial effects on microcirculation, endothelial cells and inflammation. However, evidence supporting their efficacy in improving vascular cognitive decline is limited. This trial aims to investigate the potential benefits of Tongxinluo capsules in Chinese patients with cerebral small vessel disease (CSVD) who have been diagnosed with mild cognitive impairment.

designThistrail is a randomised, double-blind, placebo-controlled, multicentre study involving 1052 individuals aged 50-80 years with MRI-confirmed CSVD and a diagnosis of mild cognitive impairment. Participants were randomly assigned in a 1:1 ratio to receive either Tongxinluo capsules or placebo. The treatment period spans 12 months, with follow-up assessments conducted every 3 months to collect cognitive scale results and other relevant data. STUDY OUTCOME: 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. DISCUSSION: 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.

Indexed as

Cerebral Small Vessel DiseasesCognitionCognitive DysfunctionDrugs, Chinese HerbalAgedAged, 80 and overCapsulesChinaDouble-Blind MethodFemaleHumansMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicTime FactorsCapsulesDrugs, Chinese HerbaltongxinluoCerebrovascular DisordersClinical TrialCognitive DysfunctionMagnetic Resonance Imaging

Identifiers

PMID40935402
PMCPMC13151870

What Socratic holds

Textmetadata
LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.