Efficacy and Safety of Jiedu Tongluo Granules for Post-stroke Depression

Study Overview
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Brief Summary
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To explore the efficacy and safety of Jiedu Tongluo granules for post stroke depression. A randomized, double-blind, placebo-controlled clinical trial was designed. The treatment group was administered the Jiedu Tongluo granules, while the control group was administered the placebo.

Official Title
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The Efficacy and Safety of Jiedu Tongluo Granules on Patients With Post-stroke Depression: a Double-blind, Randomized and Placebo-controlled Trial

Conditions
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Post-stroke Depression

Intervention / Treatment
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* Drug: Jiedu Tongluo granules
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of stroke, with neurological deficits symptoms; Clinical diagnosis of depression, according to the Diagnostic and Statistical Manual of Mental Disorders-IV （DSM-IV）or Chinese Classification and Diagnostic Criteria of Mental Disorders-3(CCMD-3), the score is between 7 to 24 by 17-item Hamilton Depression; Age of 45 to 80 years old; The patient is conscious, cooperation, without aphasia and severe cognitive impairment after acute phase of stroke; Without psychiatric disease history or family history of psychosis before stroke; No hormones and psychotropic drugs were used within 1 month before enrollment; capacity to provide written consent. Exclusion Criteria: With brain organic disease such as brain tumors; Had a history of psychiatric illness or depression before stroke; Combined with severe liver, kidney, hematopoietic system disorder; Poor glycemic control and insulin-dependent diabetes; Participate in any clinical trial or taking antidepressant treatment 1 month prior to baseline; Pregnant or breast feeding; History of sensitivity to Chinese medicine ingredients.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jiedu Tongluo granules<br>Patients in this group were administered the Jiedu Tongluo granules . | Drug: Jiedu Tongluo granules<br>* Patients in this group were administered the Jiedu Tongluo granules, 3.9mg/bag, 2 times/day for 8 weeks.<br>* Other names: The treatment group;|
| Placebo Comparator: Placebo<br>Patients in this group were administered the placebo . | Drug: Placebo<br>* Patients in this group were administered the placebo, 3.9mg/bag, 2 times/day for 8 weeks.<br>* Other names: The control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of 17-item Hamilton Depression Scale( HAMD-17) From Baseline | Depression symptoms are mainly measured by the 17-item Hamilton Depression Scale (HAMD-17) | 4weeks,8weeks | 
| Change of Barthel Index (BI) From Baseline | The daily activities will be measured using Barthel Index(BI) | 4weeks,8weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of National Institute of Health stroke scale（NIHSS）From Baseline | Neurological function mainly measured by NIHSS | 4weeks,8weeks | 
| The stroke diagnosis and evaluation criteria of Traditional Chinese Medicine（TCM）from baseline | To evaluate patients' syndrome by TCM scale | 4weeks,8weeks |