NCT05749757尚未招募不适用
The Efficacy and Safety of Acupuncture for Post COVID-19 Fatigue: a Randomized Controlled Trial
Guang'anmen Hospital of China Academy of Chinese Medical Sciences0 个研究点目标入组 84 人开始时间: 2023年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 84
- 主要终点
- The change from baseline in the Chalder Fatigue Scale (CFS) score
研究概览
简要总结
The aim of the study is to access the efficacy and safety of acupuncture for post COVID-19 fatigue.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and
- •Confirmed COVID-19 infection in the past four weeks to six months, and a negative RT PCR and/or Antigen-Based Rapid Test at present.
- •A main complaint of fatigue emerged newly following COVID-19 infection.
- •A score of ≥15 on Chalder Fatigue Scale (CFS, score range 0-33).
- •Participating the trial volunteerly and providing written informed consent.
排除标准
- •Severe anxiety and depression: a score of ≥25 on 17-item Hamilton Rating Scale for Depression (HAMD-17) and/or a score scores >29 on 14-item Hamilton Rating Scale for Anxiety (HAMA-14).
- •Significant cognitive dysfunction or suicidal tendency.
- •Usage of anti-anxiety and/or anti-depression treatments over the last three months.
- •Previously diagnosed hypothyroidism or chronic fatigue syndrome.
- •A complication of serious and poorly controlled underlying diseases.
- •Having symptoms indicating emergency or severe conditions.
- •Concurrent use of other anti-fatigue agents or treatments at present.
- •Impaired walking ability.
- •Pregnant and/or lactating or planning to get pregnant in the next 4 months.
结局指标
主要结局
The change from baseline in the Chalder Fatigue Scale (CFS) score
时间窗: Week 4
CFS evaluates physical and mental fatigue with two subscales and 11 items. Total fatigue score is obtained by summing 11 items, which were rated on a four-point Likert scale (0=better than usual, 1=no worse than usual, 2=worse than usual, and 3=much worse than usual). Higher scores indicate more severe fatigue.
次要结局
- Proportion of participants with a score of less than 15 on CFS(Weeks 4, 8, 12, and 16)
- The change from baseline in the distance of Six-Minute Walk Test (6MWT).(Weeks 4, 8 and 16)
- The proportion of participants rated as "very much improved" or "much improved" based on the Patient Global Impression-Change (PGI-C).(Weeks 4, 8, 12, and 16)
- The change from baseline in the score of Chinese Version of the Work and Social Adjustment Scale (CWSAS).(Weeks 4, 8, 12, and 16)
- The change from baseline in the score of Physical Health Questionnaire-9 (PHQ-9)(Weeks 4 and 16)
- The change from baseline in the score of General Anxiety Disorder-7 (GAD-7).(Weeks 4 and 16)
- The change from baseline in the score of Insomnia Severity Index (ISI).(Weeks 4, 8, 12, and 16)
- The change from baseline in the Chalder Fatigue Scale (CFS) score(Weeks 8, 12, and 16)
- The change from baseline in the score of physical function dimension of Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36).(Weeks 4, 8, 12, and 16)
- The change from baseline in the score of Montreal Cognitive Assessment (MoCA).(Weeks 4 and 16)
- The change from baseline in the score of Patient Health Questionnaire-15 (PHQ-15) score.(Weeks 4 and 16)
研究者
Yuanjie Sun
Principal Investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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