NCT06739720 RCT of Efficacy and Safety of CP003 on CFS/ME or Post COVID-19 Fatigue
| NCT ID | NCT06739720 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | The University of Hong Kong |
| Condition | Chronic Fatigue Syndrome (CFS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2025-01-02 |
| Primary Completion | 2026-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 130 participants in total. It began in 2025-01-02 with a primary completion date of 2026-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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)
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06739720 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 60 Years, studying Chronic Fatigue Syndrome (CFS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06739720 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06739720 currently recruiting?
Yes, NCT06739720 is actively recruiting participants. Contact the research team at tlfong@hku.hk for enrollment information.
Where is the NCT06739720 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT06739720 clinical trial?
NCT06739720 is sponsored by The University of Hong Kong. The trial plans to enroll 130 participants.