The Efficacy and Safety of Jiedu Tongluo Granules on Patients With Post-stroke Depression: a Double-blind, Randomized and Placebo-controlled Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Change of 17-item Hamilton Depression Scale( HAMD-17) From Baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Jiedu Tongluo granules
Patients in this group were administered the Jiedu Tongluo granules .
干预措施: Jiedu Tongluo granules (Drug)
Placebo
Patients in this group were administered the placebo .
干预措施: Placebo (Drug)
结局指标
主要结局
Change of 17-item Hamilton Depression Scale( HAMD-17) From Baseline
时间窗: 4weeks,8weeks
Depression symptoms are mainly measured by the 17-item Hamilton Depression Scale (HAMD-17)
Change of Barthel Index (BI) From Baseline
时间窗: 4weeks,8weeks
The daily activities will be measured using Barthel Index(BI)
次要结局
- Change of National Institute of Health stroke scale（NIHSS）From Baseline(4weeks,8weeks)
- The stroke diagnosis and evaluation criteria of Traditional Chinese Medicine（TCM）from baseline(4weeks,8weeks)