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

Recruiting

Phase Early 1 Results N/A

Trial Description

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

Interventions

  • Placebo Drug
    Intervention Desc: Patients in this group were administered the placebo, 3.9mg/bag, 2 times/day for 8 weeks.
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Patients in this group were administered the placebo .
  • Jiedu Tongluo granules Drug
    Other Names: The treatment group
    Intervention Desc: Patients in this group were administered the Jiedu Tongluo granules, 3.9mg/bag, 2 times/day for 8 weeks.
    ARM 1: Kind: Experimental
    Label: Jiedu Tongluo granules
    Description: Patients in this group were administered the Jiedu Tongluo granules .

Outcomes

Type Measure Time Frame Safety Issue
Primary Change of 17-item Hamilton Depression Scale( HAMD-17) From Baseline 4weeks,8weeks
Primary Change of Barthel Index (BI) From Baseline 4weeks,8weeks
Secondary Change of National Institute of Health stroke scale(NIHSS)From Baseline 4weeks,8weeks
Secondary The stroke diagnosis and evaluation criteria of Traditional Chinese Medicine(TCM)from baseline 4weeks,8weeks

Sponsors