An interventional study of Cordyceps sinensis mycelium culture extract (Cs4) and Matching Placebo (B) in Pneumoconiosis, sponsored by Tung Leong FONG. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Tung Leong FONG · Not applicable, Interventional, and Supportive care
This clinical trial will test whether a Cordyceps supplement improves lung function. The supplement is called Cordyceps sinensis mycelium Culture extract (Cs4). The study will include adults with pneumoconiosis, a lung disease caused by breathing in mineral dust. Researchers will also assess Cs4 safety.
The main questions are: (1) does Cs4 improve lung function compared with a placebo? (2) what health problems occur while participants take Cs4?
The study will include 84 adults aged 18 to 75 years. Their breathing condition must have been stable for at least three months. The study will take place at the School of Chinese Medicine, The University of Hong Kong.
Researchers will compare Cs4 with a placebo, a look-alike capsule containing no Cs4. Chance will determine which capsules each participant receives. Each participant has an equal chance of joining either group. Participants and researchers who assess them will not know which capsules participants receive.
Participants will: (1) take two capsules of Cs4 or placebo twice daily for 24 weeks; (2) record the capsules they take each day and return unused capsules at study visits; (3) attend clinic visits for breathing tests, a walking test, and blood tests; (4)answer questions about their breathing symptoms and daily life. (5) continue follow-up visits for 12 weeks after finishing the capsules.
Tung Leong FONG is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: (1) adults aged 18-75 years; (2) diagnosed with pneumoconiosis based on clinical and radiological criteria, including chest X-ray/computed tomography and International Labour Organization (ILO) classification; (3)stable respiratory condition for at least 3 months before enrollment, with no acute exacerbations, hospitalizations, or changes in respiratory medication; (4)able to provide written .
Exclusion Criteria:
(1) history of chronic respiratory diseases other than pneumoconiosis that may confound /FVC assessment, such as asthma, bronchiectasis, or interstitial lung disease of other etiologies; (2) known allergy to Cordyceps sinensis or any component of the study supplement; (3) pregnancy or breastfeeding; (4)severe comorbid conditions that could interfere with participation, such as active cancer, decompensated heart failure classified as (NYHA) Class III-IV, or uncontrolled psychiatric illness; (5) cognitive impairment affecting decision-making capacity.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive Cordyceps sinensis mycelium culture extract (Cs4) orally at 1.6 g per day, administered as two 0.4 g capsules twice daily for 24 weeks, followed by 12 weeks of follow-up.
Dietary Supplement: Cordyceps sinensis mycelium culture extract (Cs4)
Participants will receive matching placebo orally, administered as two capsules twice daily for 24 weeks, followed by 12 weeks of follow-up. Placebo capsules will contain starch, sucrose, and food-grade colorants and will match Cs4 capsules in size, color, weight, smell, and packaging.
Other: Matching Placebo (B)
Cordyceps sinensis Mycelium Culture Extract (Cs4) is a fermented mycelial preparation of Cordyceps sinensis, a fungus used in Traditional Chinese Medicine. It is produced by cultivating and fermenting the mycelium, the vegetative part of the fungus. In this trial, Cs4 is used as a dietary supplement to investigate its effects on lung function and rehabilitation outcomes in adults with pneumoconiosis.
Matching placebo capsules containing starch, sucrose, and food-grade colorants, with no Cs4 extract. The placebo capsules will match the Cs4 capsules in size, color, weight, and smell and will be supplied in identical blister packs to maintain blinding. Participants will take two capsules orally twice daily for 24 weeks.
Forced Expiratory Volume in One Second/ Forced Vital Capacity (FEV1/FVC) ratio
Forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) will be measured by trained, blinded assessors using standardized spirometry according to American Thoracic Society/European Respiratory Society standards.
Time frame: from baseline to week 24
Forced Expiratory Volume in One Second (FEV1)
Change from baseline in FEV1, measured in liters by spirometry according to American Thoracic Society/European Respiratory Society standards.
Time frame: Baseline, week 12, week 24, and week 36
Forced Vital Capacity (FVC)
Change from baseline in FVC, measured in liters by spirometry according to American Thoracic Society/European Respiratory Society standards.
Time frame: Baseline, week 12, week 24, and week 36
Six-Minute Walk Distance (6MWD)
Change from baseline in the total distance walked during the six-minute walk test, measured in meters. A longer distance indicates greater functional exercise capacity.
Time frame: Baseline, week 12, week 24, and week 36
St. George's Respiratory Questionnaire (SGRQ) Total Score
Change from baseline in SGRQ total score, assessing overall impairment in respiratory health status. Scores range from 0 to 100, with higher scores indicating worse health status.
Time frame: Baseline, week 12, week 24, and week 36
Modified Medical Research Council (mMRC) Dyspnea Scale Score
Change from baseline in mMRC Dyspnea Scale score, assessing limitations in daily activities caused by breathlessness. Scores range from 0 to 4, with higher scores indicating greater limitation.
Time frame: Baseline, week 12, week 24, and week 36
Leicester Cough Questionnaire (LCQ) Total Score
Change from baseline in LCQ total score, assessing cough-related quality of life using 19 items across physical, psychological, and social domains. The total score ranges from 3 to 21, with higher scores indicating better quality of life.
Time frame: Baseline, week 12, week 24, and week 36
High-Sensitivity C-Reactive Protein (hs-CRP) Level
Change from baseline in blood high-sensitivity C-reactive protein (hs-CRP) concentration, measured using an immunoturbidimetric assay. Change will be calculated separately at week 24 and week 36 by subtracting the baseline concentration from the concentration at each follow-up visit.
Time frame: Baseline, week 24, and week 36
Interleukin-6 (IL-6) Level
Change from baseline in blood IL-6 concentration, measured using a high-sensitivity enzyme-linked immunosorbent assay (ELISA). Change will be calculated separately at week 24 and week 36 by subtracting the baseline concentration from the concentration at each follow-up visit.
Time frame: Baseline, week 24, and week 36
Malondialdehyde (MDA) Level
Change from baseline in blood MDA level, assessed using a thiobarbituric acid reactive substances (TBARS) assay. Change will be calculated separately at week 24 and week 36 by subtracting the baseline value from the value at each follow-up visit.
Time frame: Baseline, week 24, and week 36
Superoxide Dismutase (SOD) Activity
Change from baseline in blood SOD activity, measured using a colorimetric assay based on nitroblue tetrazolium reduction. Change will be calculated separately at week 24 and week 36 by subtracting the baseline activity from the activity at each follow-up visit.
Time frame: Baseline, week 24, and week 36
Glutathione Peroxidase (GPx) Activity
Change from baseline in blood GPx activity, measured using a coupled enzyme assay based on nicotinamide adenine dinucleotide phosphate (NADPH) oxidation. Change will be calculated separately at week 24 and week 36 by subtracting the baseline activity from the activity at each follow-up visit.
Time frame: Baseline, week 24, and week 36
No study locations are listed for this record.
Plan to share: Yes — De-identified individual participant data underlying the results reported in the primary study publication will be shared, together with a data dictionary. Shared data will include participant characteristics, treatment allocation, lung function measurements, six-minute walk distance, questionnaire scores, biomarker results, and adverse event data used in the published analyses. Direct identifiers and the participant identification linkage file will not be shared. Access will be provided to qualified researchers following approval of a research proposal and execution of a data use agreement. Sharing will be subject to any required institutional review board (IRB) and institutional approvals and must be consistent with participant consent.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: De-identified individual participant data and the selected supporting documents will be available from publication of the primary study results until five years after study completion.
Access criteria: De-identified individual participant data underlying the published results, the data dictionary, and the selected supporting documents will be available to qualified researchers upon reasonable request. Requests should be submitted by email to the principal investigator and include a methodologically sound research proposal and statistical analysis plan. The principal investigator will review requests for scientific merit, feasibility, and consistency with participant consent and institutional requirements. Approved researchers may use the data only for analyses specified in the approved proposal. Access will require a signed data use agreement and any necessary IRB and institutional approvals. Data will be provided through secure transfer.
Start is estimated for Dec 2026; primary completion for Mar 2028, 14 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pneumoconiosis
Tung Leong FONG