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

Post-stroke Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03147053
• Other study ID #: XiyuanH
• Status: Completed
• Phase: Early Phase 1
• Start date: April 27, 2017
• Est. completion date: January 24, 2018

Study information

• Verified date: April 2017
• Source: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 24, 2018
• Est. primary completion date: July 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Post-stroke Depression
• Stroke

Intervention

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

Locations

Country	Name	City	State
China	Xiyuan Hospital of China Academy of Chinese Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xiyuan Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The change of cytokines IL-6? IL-8 in serum from baseline	To find the inflammation factors related with post-stroke depression	4weeks,8weeks
Primary	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
Primary	Change of Barthel Index (BI) From Baseline	The daily activities will be measured using Barthel Index(BI)	4weeks,8weeks
Secondary	Change of National Institute of Health stroke scale(NIHSS)From Baseline	Neurological function mainly measured by NIHSS	4weeks,8weeks
Secondary	The stroke diagnosis and evaluation criteria of Traditional Chinese Medicine(TCM)from baseline	To evaluate patients' syndrome by TCM scale	4weeks,8weeks