A Randomized, Waitlist-controlled Clinical Study on the Efficacy and Safety of Lingzhi-containing Dietary Supplement CP003 on Chronic Fatigue and Post-COVID Fatigue
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Mean difference in Chalder Fatigue Score
研究概览
简要总结
The goal of this clinical trial is to test if a Lingzhi supplement (CP003) helps people with chronic fatigue or post-COVID fatigue feel better. It will also check if the supplement is safe to use. The main questions it aims to answer are:
Does the Lingzhi supplement reduce fatigue symptoms? Is it safe to take? How does it affect the body's immune system and inflammation?
The investigators will compare people taking the Lingzhi supplement to those who do not receive any treatment (waitlist group) to see if it works.
Participants will:
- Take 5 capsules once daily for 6 weeks (or wait to start treatment if in waitlist group)
- Visit the clinic 2 times for blood tests (before and after taking the supplement)
- Complete questionnaires 3 times about their fatigue and quality of life (4 times participants in the waitlist group)
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
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the Fukuda diagnostic definition of CFS/ME or have persisting fatigue after the infection of SARS-CoV-2
- •Are able to complete a 6-week course of intervention;
- •Able to complete the online validated fatigue surveys.
排除标准
- •Have participated in any type of complements or herbal medicine within the past six months;
- •Have serious medical conditions that might limit their participation in this intervention;
- •Diagnosed with acute inflammation;
- •Are pregnant or are planning a pregnancy in the next 3 months.
研究组 & 干预措施
Intervention group
Participants receive CP003 capsules (5 capsules once daily) for 6 weeks, followed by a 6-week follow-up period.
干预措施: LingZhi capsule (Drug)
Waitlist group
Participants initially wait for 6 weeks after randomization without intervention. After the waiting period, participants receive the same CP003 supplement regimen (5 capsules once daily) for 6 weeks, followed by a 6-week follow-up period.
结局指标
主要结局
Mean difference in Chalder Fatigue Score
时间窗: From baseline to 6 weeks
Likert score 0-4 for 11 items, ranging 0-44, with higher scores indicating greater fatigue
次要结局
- Mean difference in Chalder Fatigue Score(From baseline to 12 weeks)
- Mean difference in 36-Item Short-Form Health Survey(from baseline to 6 week and 12 week)
- Mean difference in Fatigue Severity Score(from baseline to 6 week and 12 week)
- Mean difference in hospital anxiety and depression scale(from baseline to 6 week and 12 week)
- Mean difference in Pittsburgh sleep quality index(from baseline to 6 week and 12 week visit.)
- mean difference in Patient Reported Outcome Measurement Information System (PROMIS) Fatigue-Short Form 7A survey(from baseline to 6 week and 12 week)