跳至主要内容
临床试验/NCT02924831
NCT02924831Unknown2 期

High-tech Acupuncture for Treatment of Chronic Fatigue Syndrome - A Sino-Austrian Cooperation Randomized Controlled Trial(RCT) on Heart Rate Variability

Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2016年11月1日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
210
试验地点
1
主要终点
Chalder's Fatigue Scale Score(CFSS)

研究概览

简要总结

  1. To study the relationship between Chronic Fatigue Syndrome (CFS) and heart rate (HR) and its variability (HRV).
  2. To compare the curative effects and the HR/HRV indices between applicationa of different acupoints as well as different treatments (acupuncture and moxibustion).

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patients meeting criteria of CFS;
  • Aged from 18-65;
  • With no skin lesions for the acupuncture area;
  • Sign on the Informed Consent Form;

排除标准

  • Patients who can't accept and are afraid of acupuncture in the acupuncture group.
  • Patients suffering from heart and cerebrovascular diseases, serious lung disease, diabetes, neurological diseases, or severe primary diseases such as those of liver, kidney and the hematopoietic system.
  • Persons suffering from a mental disease, Alzheimer's disease or cancer.
  • Persons who have taken qi-reinforcing Chinese herbal medicine in the week preceding the investigation.
  • Pregnant women and nursing mothers.
  • Persons suffering from thrombocytopenia and abnormalities of blood coagulation function.
  • Persons with alcohol and drug abuse history.

结局指标

主要结局

Chalder's Fatigue Scale Score(CFSS)

时间窗: Two years

In CFSS, symptoms of fatigue are assessed by scores ranging from 0 to 3.

次要结局

  • Deficiency of Qi Scale Score (DQSS)(Two years)
  • Numeric Rating Scale(NRS)(Two years)
  • 36-item Short-Form Health Survey (SF-36)(Two years)
  • Low frequency(LF)(Two years)
  • High frequency (HF)(Two years)
  • Total Power(TP)(Two years)
  • LF/HF(Two years)
  • Ultra-low frequency(ULF)(Two years)
  • Very low frequency(Two years)

研究者

发起方
Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验