Post-stroke Depression
Conditions
Brief summary
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.
Interventions
DRUGJiedu Tongluo granules
Patients in this group were administered the Jiedu Tongluo granules, 3.9mg/bag, 2 times/day for 8 weeks.
DRUGPlacebo
Patients in this group were administered the placebo, 3.9mg/bag, 2 times/day for 8 weeks.
Sponsors
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of 17-item Hamilton Depression Scale( HAMD-17) From Baseline | 4weeks,8weeks | Depression symptoms are mainly measured by the 17-item Hamilton Depression Scale (HAMD-17) |
| Change of Barthel Index (BI) From Baseline | 4weeks,8weeks | The daily activities will be measured using Barthel Index(BI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of National Institute of Health stroke scale（NIHSS）From Baseline | 4weeks,8weeks | Neurological function mainly measured by NIHSS |
| The stroke diagnosis and evaluation criteria of Traditional Chinese Medicine（TCM）from baseline | 4weeks,8weeks | To evaluate patients' syndrome by TCM scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| The change of cytokines IL-6、 IL-8 in serum from baseline | 4weeks,8weeks | To find the inflammation factors related with post-stroke depression |
Countries
China
Outcome results
None listed