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

Primary Purpose

Post-stroke Depression

Status
Completed
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Jiedu Tongluo granules
Placebo
Sponsored by
Xiyuan Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-stroke Depression

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Xiyuan Hospital of China Academy of Chinese Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Jiedu Tongluo granules

Placebo

Arm Description

Patients in this group were administered the Jiedu Tongluo granules .

Patients in this group were administered the placebo .

Outcomes

Primary Outcome Measures

Change of 17-item Hamilton Depression Scale( HAMD-17) From Baseline
Depression symptoms are mainly measured by the 17-item Hamilton Depression Scale (HAMD-17)
Change of Barthel Index (BI) From Baseline
The daily activities will be measured using Barthel Index(BI)

Secondary Outcome Measures

Change of National Institute of Health stroke scale（NIHSS）From Baseline
Neurological function mainly measured by NIHSS
The stroke diagnosis and evaluation criteria of Traditional Chinese Medicine（TCM）from baseline
To evaluate patients' syndrome by TCM scale

Full Information

First Posted
May 1, 2017
Last Updated
August 20, 2019
Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03147053
Brief Title
Efficacy and Safety of Jiedu Tongluo Granules for Post-stroke Depression
Official Title
The Efficacy and Safety of Jiedu Tongluo Granules on Patients With Post-stroke Depression: a Double-blind, Randomized and Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 27, 2017 (Actual)
Primary Completion Date
July 7, 2017 (Actual)
Study Completion Date
January 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Jiedu Tongluo granules
Arm Type
Experimental
Arm Description
Patients in this group were administered the Jiedu Tongluo granules .
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients in this group were administered the placebo .
Intervention Type
Drug
Intervention Name(s)
Jiedu Tongluo granules
Other Intervention Name(s)
The treatment group
Intervention Description
Patients in this group were administered the Jiedu Tongluo granules, 3.9mg/bag, 2 times/day for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
The control group
Intervention Description
Patients in this group were administered the placebo, 3.9mg/bag, 2 times/day for 8 weeks.
Primary Outcome Measure Information:
Title
Change of 17-item Hamilton Depression Scale( HAMD-17) From Baseline
Description
Depression symptoms are mainly measured by the 17-item Hamilton Depression Scale (HAMD-17)
Time Frame
4weeks,8weeks
Title
Change of Barthel Index (BI) From Baseline
Description
The daily activities will be measured using Barthel Index(BI)
Time Frame
4weeks,8weeks
Secondary Outcome Measure Information:
Title
Change of National Institute of Health stroke scale（NIHSS）From Baseline
Description
Neurological function mainly measured by NIHSS
Time Frame
4weeks,8weeks
Title
The stroke diagnosis and evaluation criteria of Traditional Chinese Medicine（TCM）from baseline
Description
To evaluate patients' syndrome by TCM scale
Time Frame
4weeks,8weeks
Other Pre-specified Outcome Measures:
Title
The change of cytokines IL-6、 IL-8 in serum from baseline
Description
To find the inflammation factors related with post-stroke depression
Time Frame
4weeks,8weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianxun Liu
Organizational Affiliation
xiyuan hospital
Official's Role
Study Director
Facility Information:
Facility Name
Xiyuan Hospital of China Academy of Chinese Medical Sciences
City
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29747670
Citation
Zhao AM, Qiu WR, Mao LJ, Ren JG, Xu L, Yao MJ, Bilinksi K, Chang D, Liu JX. The efficacy and safety of Jiedu Tongluo granules for treating post-stroke depression with qi deficiency and blood stasis syndrome: study protocol for a randomized controlled trial. Trials. 2018 May 10;19(1):275. doi: 10.1186/s13063-018-2633-4.
Results Reference
derived

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

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