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Clinical study of Kaixin Changyu granule in the treatment of post-stroke depression

Clinical study of Kaixin Changyu granule in the treatment of post-stroke depression

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004842
Enrollment
Unknown
Registered
2021-05-14
Start date
2021-05-17
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Post stroke depression

Interventions

Sponsors

The First Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Refer to the "Key Points for Diagnosis of Various Cerebrovascular Diseases" revised by the Chinese Medical Association to be diagnosed with stroke; 2. According to the "Chinese Classification and Diagnosis of Mental Disorders-Third Edition" (CCMD-III), subjects diagnosed with secondary mild to moderate depression, Hamilton Depression Scale (HAMD-17) 17 items Score between 7 and 24 points; 3. The age of the subject is between 40 and 80 years old, regardless of gender; 4. Patients who were diagnosed with depression for the first time after stroke (diagnosed as PSD within 6 months after stroke); 5. No history of mental illness or family history of mental illness before stroke; 6. Normal consciousness can cooperate with various examinations, no aphasia or severe cognitive impairment, mental status examination (MMSE score)> 17 points; 7. Liver and kidney function tests are normal; 8. Be able to provide a voluntary signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Participate in any other clinical trials or take hormones and psychotropic drugs within the last 1 month; 2. Unstable vital signs, poor control of underlying diseases, or serious systemic diseases such as heart disease or malignant tumors; 3. Allergic to the ingredients of Kaixin Changyu Granules; 4. Pregnant or lactating women; 5. Magnetic resonance contraindications.

Design outcomes

Primary

MeasureTime frame
Homocysteine;High sensitivity C-reactive protein;Related scales;FA value of DTI;

Secondary

MeasureTime frame
Incidence of adverse reactions;

Countries

china

Contacts

Public ContactLiu Yong

The First Affiliated Hospital of Dalian Medical University

fuwa52008@126.com+86 18098876656

Outcome results

None listed

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