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A Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Shuganjieyu Capsules in the Treatment of Post-stroke Depression

A Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Shuganjieyu Capsules in the Treatment of Post-stroke Depression

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071000
Enrollment
Unknown
Registered
2023-04-28
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Post-stroke depression

Interventions

The Control Group :Placebo
The Experimental Group:Shuganjieyujiaonang

Sponsors

Tongji Medical College of Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 75 years old, males or females. 2.Ischemic stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI). 3.Meeting the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-V) diagnostic criteria for post-stroke depression (PSD) (duration of symptoms = 2 weeks). 4.18 = HAMD-17 score = 24 before treatment. 5.Signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Brain dysfunction caused by other non-vascular causes (such as primary brain tumors, brain metastases, subdural hematoma, post-seizure paralysis, brain trauma, etc.). 2. Previous history of depression, dementia and mental illness; Previous antidepressant treatment. 3. Impaired vision, hearing, speech expression, consciousness and comprehension (MMSE1.5 times the upper limit of normal. 8. Patients with renal insufficiency (eGFR 11 × 109 /L) 10. Severe diseases such as rheumatism, rheumatoid disease, vasculitis and tumor 11.PSD with psychiatric symptoms or severe PSD with suicide risk. 12. Patients with bipolar disorder were found during follow-up. 13. Patients assessed by the investigator as unsuitable for inclusion or unable to complete the interview. 14. Those who have taken Shuganjieyu Capsules in the past 1 month; Patients with serious adverse reactions to Shuganjieyu Capsule.

Design outcomes

Primary

MeasureTime frame
HAMD-17;

Secondary

MeasureTime frame
HAMA;NIHSS;BI;mRS;MMSE;SDS;PARS-3;FSS;ESS;ISI;GAD-7;PHQ-9;PHQ-15;PDQ-D-20;PSQI;SS-QOL;EPQ;

Countries

China

Contacts

Public ContactZhu Suiqiang

Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

zhusuiqiang@163.com+86 13035101141

Outcome results

None listed

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