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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
55
Patients in this group were administered the Jiedu Tongluo granules, 3.9mg/bag, 2 times/day for 8 weeks.
Patients in this group were administered the placebo, 3.9mg/bag, 2 times/day for 8 weeks.
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, China
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)
Time frame: 4weeks,8weeks
Change of Barthel Index (BI) From Baseline
The daily activities will be measured using Barthel Index(BI)
Time frame: 4weeks,8weeks
Change of National Institute of Health stroke scale(NIHSS)From Baseline
Neurological function mainly measured by NIHSS
Time frame: 4weeks,8weeks
The stroke diagnosis and evaluation criteria of Traditional Chinese Medicine(TCM)from baseline
To evaluate patients' syndrome by TCM scale
Time frame: 4weeks,8weeks
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