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

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ClinicalTrials.gov Identifier: NCT03147053
Recruitment Status : Recruiting
First Posted : May 10, 2017
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Xiyuan Hospital of China Academy of Chinese Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Post-stroke Depression Drug: Jiedu Tongluo granules Drug: Placebo Early Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Jiedu Tongluo Granules on Patients With Post-stroke Depression: a Double-blind, Randomized and Placebo-controlled Trial
Actual Study Start Date : April 27, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: Jiedu Tongluo granules
Patients in this group were administered the Jiedu Tongluo granules .
Drug: Jiedu Tongluo granules
Patients in this group were administered the Jiedu Tongluo granules, 3.9mg/bag, 2 times/day for 8 weeks.
Other Name: The treatment group
Placebo Comparator: Placebo
Patients in this group were administered the placebo .
Drug: Placebo
Patients in this group were administered the placebo, 3.9mg/bag, 2 times/day for 8 weeks.
Other Name: The control group



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03147053


Contacts
Contact: Aimei Zhao +8601062835609 zhaoaimei@bucm.edu.cn

Locations
China
Xiyuan Hospital of China Academy of Chinese Medical Sciences Recruiting
Beijing, China
Contact: Aimei Zhao    +8601062835609    zhaoaimei@bucm.edu.cn   
Sponsors and Collaborators
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Investigators
Study Director: Jianxun Liu xiyuan hospital

Responsible Party: Xiyuan Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03147053     History of Changes
Other Study ID Numbers: XiyuanH
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders