NCT06739720尚未招募2 期
A Randomized, Waitlist-controlled Clinical Study on the Efficacy and Safety of Lingzhi-containing Dietary Supplement CP003 on Chronic Fatigue and Post-COVID Fatigue
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 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?
Researchers will compare people taking the Lingzhi supplement to those who don't take anything (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 questionnaires for 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
Experimental
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)
结局指标
主要结局
Mean difference in Chalder Fatigue Score
时间窗: From baseline to 6 weeks
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 (PROMIS) Short Form Fatigue 7A survey(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.)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
A Study of Shengbai Oral Formula to Assess Safety and Alleviation of Adverse Effects in Cancer Patients Undergoing ChemotherapyCancerNCT06706752Sutter Health30
招募中
3 期
A Study of Comparing Overall Improvement of Patients With Spondyloarthritis Treated With Jitongning Tablets and PlaceboAnkylosing SpondylitisNCT06000956Tasly Pharmaceutical Group Co., Ltd408
Unknown
2 期
Dapsone for Acute Ischemia Stroke StudyCerebral StrokeCerebrovascular Accident, AcuteCerebrovascular StrokeStroke, AcuteStrokeNCT01144650Cidat, S.A. de C.V.300
尚未招募
不适用
Clinical Study of De-Stress & Happy Gut Powder for Stress and Indigestion in Adults.StressIndigestionDyspepsiaNCT06568965Herbolab India Pvt. Ltd.81
终止
3 期
Low-dose HCG as an Adjunct to Ovarian Stimulation in Subfertile Women Undergoing ARTHCG; IVF; Pregnancy Rates; ART; Chorionic GonadotropinNCT03423537National and Kapodistrian University of Athens80