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Shengqing Tongqiao Prescription for patients with mild cognitive impairment in white matter lesions: a randomized, double-blind, double-simulation, parallel controlled clinical study

Shengqing Tongqiao Prescription for patients with mild cognitive impairment in white matter lesions: a randomized, double-blind, double-simulation, parallel controlled clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068552
Enrollment
Unknown
Registered
2023-02-23
Start date
2022-07-20
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

patients with mild cognitive impairment in cerebral white matter lesions

Interventions

Treatment Group:Western medicine standard treatment+Shengqing Tongqiao prescription + Ginkgo leaf tablets simulator
Control Group:Western medicine standard treatment+Shengqing Tongqiao prescription simulator + Ginkgo leaf tablets

Sponsors

Yueyang Hospital of Intergrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Both met the western diagnostic criteria for leukoencephalopathy (confirmed by head MRI in the last 3 months) and mild cognitive impairment; (2) Head MRI showed Fazekes score =2 in patients with high white matter signal; (3) MoCA score: illiterate group =13 points, primary school group =19 points, middle school and above group =24 points; (4) Regardless of gender, age =50 and =80; (5) Understand and agree to participate in this study and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with cerebral hemorrhage, cerebral infarction (infarction focal diameter =15mm), neurological degeneration disease, neurological infection, neurological tumor, etc.; (2) Mild cognitive impairment caused by other non-ischemic white matter lesions, such as CO poisoning, hydrocephalus, immune brain injury, thyroid disease, etc.; (3) Dementia patients (MMSE: illiterate =17 points, primary school =20 points, middle school (including technical secondary school) =22 points, university (including junior college) =23 points); (4) received drugs to improve cognitive function, such as Donepezil, Memantine, vitamin D, etc., within 3 months; (5) participating in other clinical trials in the past 3 months; (6) those who have serious diseases of heart, liver, kidney and hematopoietic system, malignant tumors or mental diseases and cannot cooperate; (7) Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Montreal Cognitive Assessment (MoCA);

Secondary

MeasureTime frame
Mini-Mental State Examination (MMSE);Auditory Verbal Learning Test (AVLT);Stroop Color Word Test (SCWT);Shape Trails Test (STT);Digit Span Test (DST);Symbol Digit Modalities Test (SDMT);Boston Naming Test (BNT);Rey complex figure test (RCFT);Verbal fluency test (VFT);Clock drawing test (CDT);Hamilton Depression Scale (HAMD);Hamilton Anxiety Scale (HAMA);Resting-state functional magnetic resonance imaging (rs-fMRI);Self-assessment of depression (PHQ-9);Self-assessment of anxiety (GAD-7);Barthel Index (BI);Functional Activity Questionnaire (FAQ);Activities of Daily Living Scale (ADL);

Countries

China

Contacts

Public ContactYunyun Zhang

Yueyang Hospital of Intergrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

zhangyyun@hotmail.com13816134690

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026