Efficacy and Safety of Jiedu Tongluo Granules for Post-stroke Depression

The Efficacy and Safety of Jiedu Tongluo Granules on Patients With Post-stroke Depression: a Double-blind, Randomized and Placebo-controlled Trial

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.

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.