Efficacy and Safety of Jiedu Tongluo Granules for Post-stroke Depression
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|ClinicalTrials.gov Identifier: NCT03147053|
Recruitment Status : Recruiting
First Posted : May 10, 2017
Last Update Posted : May 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Post-stroke Depression||Drug: Jiedu Tongluo granules Drug: Placebo||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Efficacy and Safety of Jiedu Tongluo Granules on Patients With Post-stroke Depression: a Double-blind, Randomized and Placebo-controlled Trial|
|Actual Study Start Date :||April 27, 2017|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||March 2018|
Experimental: Jiedu Tongluo granules
Patients in this group were administered the Jiedu Tongluo granules .
Drug: Jiedu Tongluo granules
Patients in this group were administered the Jiedu Tongluo granules, 3.9mg/bag, 2 times/day for 8 weeks.
Other Name: The treatment group
Placebo Comparator: Placebo
Patients in this group were administered the placebo .
Patients in this group were administered the placebo, 3.9mg/bag, 2 times/day for 8 weeks.
Other Name: The control group
- Change of 17-item Hamilton Depression Scale( HAMD-17) From Baseline [ Time Frame: 4weeks,8weeks ]Depression symptoms are mainly measured by the 17-item Hamilton Depression Scale (HAMD-17)
- Change of Barthel Index (BI) From Baseline [ Time Frame: 4weeks,8weeks ]The daily activities will be measured using Barthel Index(BI)
- Change of National Institute of Health stroke scale（NIHSS）From Baseline [ Time Frame: 4weeks,8weeks ]Neurological function mainly measured by NIHSS
- The stroke diagnosis and evaluation criteria of Traditional Chinese Medicine（TCM）from baseline [ Time Frame: 4weeks,8weeks ]To evaluate patients' syndrome by TCM scale
- The change of cytokines IL-6、 IL-8 in serum from baseline [ Time Frame: 4weeks,8weeks ]To find the inflammation factors related with post-stroke depression
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03147053
|Contact: Aimei Zhaofirstname.lastname@example.org|
|Xiyuan Hospital of China Academy of Chinese Medical Sciences||Recruiting|
|Contact: Aimei Zhao +8601062835609 email@example.com|
|Study Director:||Jianxun Liu||xiyuan hospital|