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Clinical study of ginkgo diterpene lactone glumine injection in the treatment of arteriosclerosis small cerebral vascular disease: a single center, self-controlled study

Clinical study of ginkgo diterpene lactone glumine injection in the treatment of arteriosclerosis small cerebral vascular disease: a single center, self-controlled study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050965
Enrollment
Unknown
Registered
2021-09-08
Start date
2021-09-08
Completion date
Unknown
Last updated
2022-05-16

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

Conditions

cerebral small vessel disease (CSVD)

Interventions

Sponsors

The Third Affiliated Hospital of 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 existence 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 disorder, vascular parkinsonism, mental or emotional disorders (anxiety, depression, etc.), sleep disturbance, 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) At least one of the following imaging markers: white matter hyperintensity (Fazekas >= grade 2), microbleeds (deep >= 1), enlarged perivascular space (basal ganglia >= 10); 5. The subject or legal guardian 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 have been diagnosed with Alzheimer's disease and other types of dementia, or Parkinson's disease, or other severe mental disorders; 6. Patients who cannot accept head MRI examination; 7. Patients with known renal impairment (eGFR185/110mmHg) that cannot be controlled by drugs; 15. Fasting blood glucose 22.2mmol/L; 16. Past history of drug, alcohol or drug abuse; 17. Patients who are known to be allergic to the test drug; 18. Participated in other clinical trials 3 months before the start of this study; 19. The researcher believes that it is not suitable to participate in this research.

Design outcomes

Primary

MeasureTime frame
blood oxygen level dependent fMRI;dynamic enhanced MRI;high-density electroencephalogram;sleep scale;anxiety scale;depression scale;ambulatory blood pressure;

Countries

China

Contacts

Public ContactLu Zhengqi

The Third Affiliated Hospital of Sun Yat-Sen University

lzq1828@aliyun.com+86 13570102668

Outcome results

None listed

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