Chronic Fatigue Syndrome (CFS)Phase 2/3NCT06739720
RCT of Efficacy and Safety of CP003 on CFS/ME or Post COVID-19 Fatigue
A Phase 2/3 study testing LingZhi capsule in people with Chronic Fatigue Syndrome (CFS) and Post-COVID ME/CFS, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Chronic Fatigue Syndrome (CFS), Post-COVID ME/CFS
- What is being tested?
- LingZhi capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Jan 2025to 31 Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Specialist Clinical Centre for Teaching and Research, School of Chinese Medicine, The University of Hong Kong
Hong Kong
TUNG LEONG FONG, +852 5660 4020, tlfong@hku.hk
About this study
Official title: A Randomized, Waitlist-controlled Clinical Study on the Efficacy and Safety of Lingzhi-containing Dietary Supplement CP003 on Chronic Fatigue and Post-COVID Fatigue
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?
Read more
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)
- Conditions
- Chronic Fatigue Syndrome (CFS), Post-COVID ME/CFS
- Being tested
- LingZhi capsule
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LingZhi capsuleDrug
Lingzhi-containing capsules (CP003) is a Chinese Medicine nutritional supplement manufactured by Chinese Pharm Co., Ltd, containing: wild red ganoderma extract, ganoderma spore powder (99.9% broken-wall), β-nicotinamide mononucleotide (NMN), wild yellow ganoderma extract, wild green ganoderma extract, wild purple ganoderma extract, wild white ganoderma extract, wild black ganoderma extract
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants receive CP003 capsules (5 capsules once daily) for 6 weeks, followed by a 6-week follow-up period. Receives: Drug: LingZhi capsule |
| Waitlist group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference in Chalder Fatigue Score
Likert score 0-4 for 11 items, ranging 0-44, with higher scores indicating greater fatigue
Measured: From baseline to 6 weeks
Secondary outcomes (6)
Mean difference in Chalder Fatigue Score
Likert score 0-4 for 11 items, ranging 0-44, with higher scores indicating greater fatigue
Measured: From baseline to 12 weeks
Mean difference in 36-Item Short-Form Health Survey
ranging 0-100, with higher scores indicating better health status
Measured: from baseline to 6 week and 12 week
Mean difference in Fatigue Severity Score
Likert score 1-7 for 9 items, ranging 9-63, where higher scores indicate more severe fatigue
Measured: from baseline to 6 week and 12 week
mean difference in Patient Reported Outcome Measurement Information System (PROMIS) Fatigue-Short Form 7A survey
a 5-point Likert scale of 7 items, ranging 0-35, with higher scores indicating greater fatigue
Measured: from baseline to 6 week and 12 week
Mean difference in hospital anxiety and depression scale
ranging 0-21, with higher scores indicating more severe symptoms
Measured: from baseline to 6 week and 12 week
Mean difference in Pittsburgh sleep quality index
ranging 0-21, with higher scores indicating worse sleep quality
Measured: from baseline to 6 week and 12 week visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start2 Jan 2025
- Primary completion15 Jan 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Fatigue Syndrome (CFS)Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in a 1:1 ratio to either the intervention group or the waitlist group. The intervention group receives CP003 capsules (5 capsules once daily) for 6 weeks. The waitlist group undergoes a 6-week waiting period without any treatment.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Innovation and Technology Commission, Hong Kong
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739720
- Sponsor's protocol ID
- HKWC-2024-320
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Xun Y, Fong TL, Chen G, Feng Y, Chan L, Wang N. Effectiveness and Safety of a Supplement Containing a Pharmacologically Active Basidiomycete Mushroom for Chronic Fatigue and Post-COVID-19 Fatigue Syndrome: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Jan 20;15:e82633. doi: 10.2196/82633.
PubMed 41558017
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Waitlist-controlled Clinical Study on the Efficacy and Safety of Lingzhi-containing Dietary Supplement CP003 on Chronic Fatigue and Post-COVID Fatigue
- ClinicalTrials.gov ID
- NCT06739720
- Acronym / sponsor ID
- HKWC-2024-320
- Conditions
- Chronic Fatigue Syndrome (CFS), Post-COVID ME/CFS
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Innovation and Technology Commission, Hong Kong
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to either the intervention group or the waitlist group. The intervention group receives CP003 capsules (5 capsules once daily) for 6 weeks. The waitlist group undergoes a 6-week waiting period without any treatment.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: LingZhi capsuleParticipants receive CP003 capsules (5 capsules once daily) for 6 weeks, followed by a 6-week follow-up period. |
| Waitlist group | No intervention | –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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LingZhi capsuleLingzhi-containing capsules (CP003) is a Chinese Medicine nutritional supplement manufactured by Chinese Pharm Co., Ltd, containing: wild red ganoderma extract, ganoderma spore powder (99.9% broken-wall), β-nicotinamide mononucleotide (NMN), wild yellow ganoderma extract, wild green ganoderma extract, wild purple ganoderma extract, wild white ganoderma extract, wild black ganoderma extract | Drug | Intervention group |
Primary outcome
Mean difference in Chalder Fatigue Score
Time frame: From baseline to 6 weeks
Likert score 0-4 for 11 items, ranging 0-44, with higher scores indicating greater fatigue
6 secondary outcomes
Mean difference in Chalder Fatigue Score
Time frame: From baseline to 12 weeks
Mean difference in 36-Item Short-Form Health Survey
Time frame: from baseline to 6 week and 12 week
Mean difference in Fatigue Severity Score
Time frame: from baseline to 6 week and 12 week
mean difference in Patient Reported Outcome Measurement Information System (PROMIS) Fatigue-Short Form 7A survey
Time frame: from baseline to 6 week and 12 week
Mean difference in hospital anxiety and depression scale
Time frame: from baseline to 6 week and 12 week
Mean difference in Pittsburgh sleep quality index
Time frame: from baseline to 6 week and 12 week visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Derived from this study: PubMed 41558017Xun Y, Fong TL, Chen G, Feng Y, Chan L, Wang N. Effectiveness and Safety of a Supplement Containing a Pharmacologically Active Basidiomycete Mushroom for Chronic Fatigue and Post-COVID-19 Fatigue Syndrome: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Jan 20;15:e82633. doi: 10.2196/82633.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing LingZhi capsule in people with Chronic Fatigue Syndrome (CFS) and Post-COVID ME/CFS, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact TUNG LEONG FONG (+852 5660 4020, tlfong@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference in Chalder Fatigue Score (time frame: From baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06739720, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.