Clinical trial NCT03147053: Efficacy and Safety of Jiedu Tongluo Granules for Post-stroke Depression
Official title: The Efficacy and Safety of Jiedu Tongluo Granules on Patients With Post-stroke Depression: a Double-blind, Randomized and Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Post-stroke Depression
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 55
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change of 17-item Hamilton Depression Scale( HAMD-17) From Baseline
timeFrame: 4weeks,8weeks
measure: Change of Barthel Index (BI) From Baseline
timeFrame: 4weeks,8weeks
Secondary outcomes:
measure: Change of National Institute of Health stroke scale（NIHSS）From Baseline
timeFrame: 4weeks,8weeks
measure: The stroke diagnosis and evaluation criteria of Traditional Chinese Medicine（TCM）from baseline
timeFrame: 4weeks,8weeks
Other outcomes:
measure: The change of cytokines IL-6、 IL-8 in serum from baseline
timeFrame: 4weeks,8weeks
Locations:
city: Beijing
country: China
facility: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Study officials:
affiliation: xiyuan hospital
name: Jianxun Liu
role: STUDY_DIRECTOR
References:
citation: 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.