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

NCT ID: NCT03147053

Last Updated: 2019-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-27
• Study Completion Date: 2018-01-24

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.

Conditions

Post-stroke Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Jiedu Tongluo granules

Patients in this group were administered the Jiedu Tongluo granules .

Group Type: EXPERIMENTAL

Jiedu Tongluo granules

Intervention Type: DRUG

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 .

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients in this group were administered the placebo, 3.9mg/bag, 2 times/day for 8 weeks.

Interventions

Jiedu Tongluo granules

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

Intervention Type: DRUG

Placebo

Patients in this group were administered the placebo, 3.9mg/bag, 2 times/day for 8 weeks.

Intervention Type: DRUG

Other Intervention Names

The treatment group; The control group

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianxun Liu

Role: STUDY_DIRECTOR

xiyuan hospital

Locations

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 29747670 (View on PubMed)

Other Identifiers

XiyuanH

Identifier Type: -

Identifier Source: org_study_id