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Clinical study of Huazhuo Huoxue Decoction in the treatment of post-stroke cognitive impairment

Clinical study of Huazhuo Huoxue Decoction in the treatment of post-stroke cognitive impairment

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001625
Enrollment
Unknown
Registered
2026-06-26
Start date
2025-11-20
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Post-stroke cognitive impairment

Interventions

Control Group:Basic treatment (antiplatelet + statins) + placebo
Nimodipine group:Basic treatment (antiplatelet + statins) + nimodipine tablets.
Turbidity-Clearing and Blood-Activating Formula:Basic treatment (antiplatelet + statins) + Lipid-clearing and Blood-activating Formula
Nimodipine + Hua Zhuo Huoxue Formula Regimen:Basic treatment (antiplatelet + statins) + Nimodipine tablets + Hua Huo

Sponsors

Hebei Provincial Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Participants who meet the clinical diagnostic criteria for ischemic stroke and cognitive impairment in Western medicine, as well as the diagnostic criteria for stroke disease, dementia, and phlegm-stasis intermingled syndrome in traditional Chinese medicine; (2) Participants aged between 40 and 75 years, with no restrictions on gender; (3) Participants with an educational level of elementary school or above; (4) Participants with post-stroke cognitive impairment occurring within 1 to 6 months after cerebral infarction, with stable condition and vital signs; (5) Participants with MMSE and MOCA scores ranging from 10 to 26 points; (6) Participants who have not taken any medications for post-stroke cognitive impairment in the past 3 months; (7) Participants who comply with the principles of voluntariness and informed consent in this clinical study.

Exclusion criteria

Exclusion criteria: (1) Those who do not meet the above inclusion criteria; (2) Excluding cognitive impairment caused by intracerebral hemorrhage; (3) Excluding severe post-stroke cognitive impairment, with MMSE scores below 10 points and MOCA scores below 10 points; (4) Excluding severe diseases such as heart disease, liver and kidney dysfunction, hematological disorders, and malignant tumors, as well as mental disorders such as depression and anxiety; (5) Excluding individuals with other types of diseases, such as Alzheimer's disease, cerebral small vessel disease, or brain tissue damage, that may lead to cognitive decline; (6) Pregnant and breastfeeding women; (7) Patients with liver or kidney damage, or those allergic to the drugs used in this experiment; (8) Patients who disagree or are uncooperative with this experiment.

Design outcomes

Primary

MeasureTime frame
Mini-Mental State Examination;

Secondary

MeasureTime frame
Montessori Cognitive Assessment Scale;Activities of Daily Living Scale;Tumor Necrosis Factor-alpha, Interleukin-1 beta, Interleukin-6;

Countries

China

Contacts

Public ContactWei Ma

Hebei Provincial Traditional Chinese Medicine Hospital

15075181182@163.com15833217521

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026