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

Early Phase 1

Completed

• Conditions: Post-stroke Depression
• Interventions: Drug: Placebo; Drug: Jiedu Tongluo granules

• Registration Number: NCT03147053
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-04
• Study Start: 2017-04-27
• Study First Submitted: 2017-05-01
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-10
• Primary Completion: 2017-07-07
• Study Completion: 2018-01-24
• Last Update Submitted: 2019-08-20
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients in this group were administered the placebo .
Jiedu Tongluo granules	Jiedu Tongluo granules	Patients in this group were administered the Jiedu Tongluo granules .

Primary Outcome Measures

Name	Time	Method
Change of 17-item Hamilton Depression Scale( HAMD-17) From Baseline	4weeks,8weeks	Depression symptoms are mainly measured by the 17-item Hamilton Depression Scale (HAMD-17)
Change of Barthel Index (BI) From Baseline	4weeks,8weeks	The daily activities will be measured using Barthel Index(BI)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Xiyuan Hospital of China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, China