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Songling Xuemaikang Capsules for Cerebral Small Vessel Disease

NCT07271732 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-12-09

No results posted yet for this study

Summary

Cerebral small vessel disease (CSVD) is a common age-related microvascular disease related to the slow accumulation of damage to small arteries, veins, and capillaries. Hypertension is a risk factor for cerebrovascular disease, and its damage to the vascular endothelium is one of the key contributing factors to the pathogenesis of CSVD. CSVD has an insidious onset, and patients may exhibit no clinical symptoms in the early stage. Common clinical manifestations of chronic CSVD include vascular dementia, depression, gait disturbance, and abnormalities in swallowing and urinary functions. There is currently no specific treatment for CSVD.

Existing studies have shown that Songling Xuemaikang capsule (SXC) combined with antihypertensive drugs exerted significant effects on systolic blood pressure (SBP), diastolic blood pressure (DBP), 24-hour SBP, and 24-hour DBP, while also improving symptoms of hypertension. Animal experiments have demonstrated that SXC can reduce apoptosis and alleviate cerebral ischemia-reperfusion injury, exerting neuroprotective effects. Additionally, a previously completed multicenter, randomized, double-blind, non-inferiority-designed clinical trial by the team, conducted in patients with primary hypertension, showed that SXC were non-inferior to losartan potassium in reducing diastolic blood pressure. Therefore, exploring the therapeutic potential of SXC in CSVD is highly necessary.

This project is a randomized, double-blind, placebo-controlled multicenter clinical study to investigate the clinical efficacy and safety of SXC in the treatment of hypertension with CSVD. A total of 90 subjects who met the subject screening criteria are planned to be enrolled, with 45 patients in the test group and 45 patients in the placebo group.

Conditions

Interventions

DRUG

Songling Xuemaikang Capsule

3 capsules/time, tid, p.o Duration of Treatment: 1 year (12 months)

DRUG

Songling Xuemaikang Capsule Placebo

3 capsules/time, tid, p.o Duration of Treatment: 1 year (12 months)

Sponsors & Collaborators

  • Dongzhimen Hospital, Beijing

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-10
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07271732 on ClinicalTrials.gov