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A Clinical Controlled Study Investigating the Efficacy of Xingshen Jieyu Decoction in Treating Post-Stroke Depression Based on Resting-State Default Mode Network Connectivity.

A Clinical Controlled Study Investigating the Efficacy of Xingshen Jieyu Decoction in Treating Post-Stroke Depression Based on Resting-State Default Mode Network Connectivity.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001099
Enrollment
Unknown
Registered
2026-04-28
Start date
2026-01-26
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Post-stroke Depression

Interventions

Integrated Traditional Chinese and Western Medicine group:Xingshen Jieyu Decoction + Escitalopram Oxalate
Traditional Chinese Medicine treatment group:Xingshen Jieyu Decoction
Western medicine treatment group:Escitalopram Oxalate

Sponsors

Shanghai Seventh People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for moderate post-stroke depression according to Western medicine and for the liver depression and spleen deficiency syndrome according to Traditional Chinese Medicine (TCM) pattern differentiation. (2) Hamilton Depression Scale (HAMD-17) score: >17 and 17 for illiterate individuals, >20 for those with primary school education, and >24 for those with junior high school education or above, indicating clear consciousness and ability to cooperate with tests and examinations. (4) Age between 18 and 75 years. (5) No use of other antipsychotic or antidepressant medications within the 2 weeks prior to enrollment. (6) Voluntary participation with signed informed consent provided by the patient.

Exclusion criteria

Exclusion criteria: (1) Diagnosed with intracerebral hemorrhage, subarachnoid hemorrhage, or epilepsy; (2) Pre-stroke diagnosis or medical history suggesting a clearly existing depressive state; (3) Co-existing other psychiatric disorders, such as mania, schizophrenia, etc.; (4) Having severe suicidal tendencies (score on the suicide item of HAMD-17 > 2); (5) Presence of speech disorder, consciousness disorder, intellectual disability, or other conditions preventing cooperation with examinations; (6) Women who are pregnant or lactating; (7) Participation in another clinical drug study within the past month; (8) History of allergy to the study drug(s).

Design outcomes

Primary

MeasureTime frame
Hamilton depression scale;

Secondary

MeasureTime frame
Montgomery-Asberg Depression Rating Scale;Syndrome score of depression in traditional Chinese medicine;National Institutes of Health Stroke Scale;Barthel index score;Resting-state functional magnetic resonance imaging;IL33;CX3CL1;

Countries

China

Contacts

Public ContactZhenxiang Han

Shanghai 7th People's Hospital

hanxiang798007@163.com+86 177 0176 7768

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026