Skip to main content
OpenTrials
Completed

NCT Number: NCT03147053

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post-stroke Depression

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Jiedu Tongluo granules

Drug

Patients in this group were administered the Jiedu Tongluo granules, 3.9mg/bag, 2 times/day for 8 weeks.

Other names: The treatment group

Placebo

Drug

Patients in this group were administered the placebo, 3.9mg/bag, 2 times/day for 8 weeks.

Other names: The control group

Primary outcomes

  1. Change of 17-item Hamilton Depression Scale( HAMD-17) From Baseline

    Time frame: 4weeks,8weeks

    Depression symptoms are mainly measured by the 17-item Hamilton Depression Scale (HAMD-17)

  2. Change of Barthel Index (BI) From Baseline

    Time frame: 4weeks,8weeks

    The daily activities will be measured using Barthel Index(BI)

Secondary outcomes

  1. Change of National Institute of Health stroke scale（NIHSS）From Baseline

    Time frame: 4weeks,8weeks

    Neurological function mainly measured by NIHSS

  2. The stroke diagnosis and evaluation criteria of Traditional Chinese Medicine（TCM）from baseline

    Time frame: 4weeks,8weeks

    To evaluate patients' syndrome by TCM scale

Other outcomes

  1. The change of cytokines IL-6、 IL-8 in serum from baseline

    Time frame: 4weeks,8weeks

    To find the inflammation factors related with post-stroke depression

Sponsors and collaborators

Lead sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
May 10, 2017
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.