Efficacy of Acupuncture at Acupoints Group Around the Base of Skull for Post-Stroke Depression: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- The change rate of the total score of Hamilton Depression Rating Scale
研究概览
简要总结
The objective of this trial is to evaluate the efficacy and safety of electroacupuncture at acupoints group around the base of skull for post-stroke depression.
详细描述
98 eligible participants with post-stroke depression will be recruited and randomly assigned to the experimental group and the control group in a ratio of 1:1. Participants in both groups will receive electroacupuncture or placebo acupuncture treatment at acupoints group around the base of skull 3 times a week for 4 weeks, and followed up for 24 weeks.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Conforming to the criteria for the diagnosis of PSD recommended by the "Chinese Expert Consensus on Clinical Practice of Post-Stroke Depression";
- •Aged 40 to 80 years old;
- •The score of HDRS-24 item scale is more than 8 points and less than 35 points, that is, mild to moderate depression;
- •Has not received antidepressant treatment or has been discontinued for more than 2 weeks before entering treatment, and has not participated in other ongoing clinical trials.
排除标准
- •Subjects with history of mental illness or family history of mental illness;
- •Subjects with severe heart, liver, kidney, hematopoietic system, endocrine and immune system diseases;
- •Subjects with dementia, aphasia, cognitive dysfunction or unable to cooperate with examination and treatment;
- •Subjects installed with the cardiac pacemaker;
- •Pregnant or lactating patients.
研究组 & 干预措施
Experimental group
Participants will receive electroacupuncture at Yamen(DU15), bilateral Tianzhu(BL10), Fengchi(GB20), Wangu(GB12), and Yifeng(SJ17) for 30minutes, 3 times a week for 4 weeks.
干预措施: Electroacupuncture (Device)
Control group
Participants will receive shallow needle insertion of 2-3 mm at sham acupoints without manipulation for 30minutes, 3 times a week for 4 weeks.
干预措施: Sham acupuncture (Device)
结局指标
主要结局
The change rate of the total score of Hamilton Depression Rating Scale
时间窗: Baseline, week 4
The therapeutic effects are assessed based upon HDRS score-reducing rate． Cure: HDRS score-reducing rate≥75％; Remarkable effect: HDRS score-reducing rate≥50％, \<75％; Improvement: HDRS score-reducing rate≥25％, \<50％; Failure: HDRS score-reducing rate\<25％．
次要结局
- Change in the scores of National Institute of Health stroke scale (NIHSS)(Baseline, week4, week16 and week28)
- Changes in the scores of HDRS and its seven kinds of factors(Baseline, week4, week16 and week28)
- Change in the scores of Beck Depression Inventory (BDI)(Baseline, week4, week16 and week28)
- Change in the scores of Barthel Index (BI)(Baseline, week4, week16 and week28)
研究者
Zeng Yuxiao
Doctoral candidate of China Academy of Chinese Medical Sciences
China Academy of Chinese Medical Sciences