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

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Status and phase

Completed

Early Phase 1

Conditions

Post-stroke Depression

Treatments

Drug: Placebo

Drug: Jiedu Tongluo granules

Study type

Interventional

Funder types

Other

Identifiers

NCT03147053

XiyuanH

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

All

Ages

45 to 80 years old

Volunteers

No Healthy Volunteers

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.