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

• Status: Completed
• Trial end date: 2018-01-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences

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.