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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jiedu Tongluo granules | Experimental | Patients in this group were administered the Jiedu Tongluo granules . |
|
| Placebo | Placebo Comparator | Patients in this group were administered the placebo . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jiedu Tongluo granules | Drug | Patients in this group were administered the Jiedu Tongluo granules, 3.9mg/bag, 2 times/day for 8 weeks. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The change of cytokines IL-6、 IL-8 in serum from baseline | To find the inflammation factors related with post-stroke depression | 4weeks,8weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianxun Liu | xiyuan hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiyuan Hospital of China Academy of Chinese Medical Sciences | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29747670 | Derived | Zhao AM, Qiu WR, Mao LJ, Ren JG, Xu L, Yao MJ, Bilinksi K, Chang D, Liu JX. The efficacy and safety of Jiedu Tongluo granules for treating post-stroke depression with qi deficiency and blood stasis syndrome: study protocol for a randomized controlled trial. Trials. 2018 May 10;19(1):275. doi: 10.1186/s13063-018-2633-4. |
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| Placebo | Drug | Patients in this group were administered the placebo, 3.9mg/bag, 2 times/day for 8 weeks. |
|
|
To evaluate patients' syndrome by TCM scale
| 4weeks,8weeks |