Tongxinluo capsule in the treatment of cerebral small vessel disease: protocol of a randomised, double-blind, placebo-controlled, multicentre clinical study (TOPS-CSVD).

Background: Tongxinluo 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.

Design: Thistrail 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.