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Clinical study of multi-target regimen in the treatment of arteriosclerotic cerebral small vessel disease: a single-center, self-controlled study

Clinical study of multi-target regimen in the treatment of arteriosclerotic cerebral small vessel disease: a single-center, self-controlled study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049216
Enrollment
Unknown
Registered
2021-07-25
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebral small vessel disease

Interventions

Experimental group:Ginkgo bilobalide + Lipoic acid + Coenzyme Q + Mecobalt + Idibenone

Sponsors

The Third Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 60-80 years. 2. The presence of at least one of the following vascular risk factors for atherosclerosis: smoking (10 cigarettes per day, smoking age >= 10 years), BMI > 28, hypertension, diabetes, impaired fasting blood glucose or abnormal glucose tolerance, hyperlipidemia, hyperhomocysteinemia, coronary heart disease, symptomatic stroke, and obstructive sleep apnea hypopnea syndrome (OSAHS). 3. The presence of at least one of the following common chronic neurological clinical symptoms of cerebral small vessel disease: cognitive decline, gait or postural balance disorders, vascular parkinsonism, mental or emotional disorders (anxiety, depression, etc.), sleep disorders, urinary and fecal sphincter dysfunction; at least one month after acute lacunar syndrome (pure motor hemiparesis, pure sensory stroke, ataxia hemiparesis, sensorimotor stroke, dysarthria-clumsy hand syndrome, etc.). 4. Magnetic resonance imaging presence of at least two characteristic imaging markers of CSVD that meet the STRIVE criteria: (1) Necessary conditions: lacunar infarct lesions (number >= 1); (2) Contain at least one of the following imaging markers: white matter hyperintensity (Fazekas >= grade 2), microbleeds (number of deep parts >= 1), enlarged perivascular space (number of basal ganglia >= 10). 5. Subjects or legal guardians signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. More than 50% stenosis of intracranial and extracranial arteries or previous carotid endarterectomy; 2. (very) Likely cardiac stroke suggested by TOAST classification; 3. Cortical infarcts or subcortical infarcts greater than 1.5 cm in diameter on MRI (non-acute phase); white matter hyperintensity caused by other diseases such as multiple sclerosis or leukodystrophy; 4. Mini-Mental State Assessment Scale (MMSE, Appendix 3) score 27; 5. Patients who cannot accept head MRI examination; 6. Patients with known renal impairment (eGFR185/110mmHg); 14. Fasting blood glucose 22.2mmol/L; 15. Past history of drug, alcohol or drug abuse; 16. Patients who are known to be allergic to the test drug; 17. Participated in other clinical trials 3 months before the start of this study; 18. The researcher believes that it is not suitable to participate in this research.

Design outcomes

Secondary

MeasureTime frame
MRI of Brain;High Density Electroencephalogram;SDS Depression Self-Rating Scale Score;SAS Anxiety Self-Rating Scale Score;

Primary

MeasureTime frame
Montreal Cognitive Assessment Scale Score;Gait Scale Score;Pittsburgh sleep quality index ( PSQI);

Countries

China

Contacts

Public ContactLu Zhengqi

The Third Affiliated Hospital, Sun Yat-Sen University

lzq1828@aliyun.com+86 13570102668

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026