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

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

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.

Study Overview

• Status: Completed
• Conditions: Post-stroke Depression
• Intervention / Treatment: Drug: Jiedu Tongluo granules; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Xiyuan Hospital of China Academy of Chinese Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: The control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	4weeks,8weeks
Change of Barthel Index (BI) From Baseline	The daily activities will be measured using Barthel Index(BI)	4weeks,8weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of National Institute of Health stroke scale（NIHSS）From Baseline	Neurological function mainly measured by NIHSS	4weeks,8weeks
The stroke diagnosis and evaluation criteria of Traditional Chinese Medicine（TCM）from baseline	To evaluate patients' syndrome by TCM scale	4weeks,8weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of cytokines IL-6、 IL-8 in serum from baseline	To find the inflammation factors related with post-stroke depression	4weeks,8weeks

Collaborators and Investigators

• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Investigators: Study Director: Jianxun Liu, Xiyuan Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2017
• Primary Completion (Actual): July 7, 2017
• Study Completion (Actual): January 24, 2018

Study Registration Dates

• First Submitted: May 1, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (Actual): May 10, 2017

Study Record Updates

• Last Update Posted (Actual): August 21, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mood Disorders; Stroke; Depression; Depressive Disorder
• Other Study ID Numbers: XiyuanH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No