Cs4 for Pneumoconiosis Rehabilitation
Efficacy and Safety of Cordyceps Sinensis Mycelium Culture Extract (Cs4) Supplementation in Pneumoconiosis Rehabilitation: a Randomized, Controlled Trial
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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Tung Leong Fong
- Telefonní číslo: +852 5660 4020
- E-mail: u3557512@connect.hku.hk
Studijní záloha kontaktů
- Jméno: Yunqing Xun
- Telefonní číslo: +852 5229 5427
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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 informed consent.
Exclusion Criteria:
(1) history of chronic respiratory diseases other than pneumoconiosis that may confound FEV1/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 New York Heart Association (NYHA) Class III-IV, or uncontrolled psychiatric illness; (5) cognitive impairment affecting decision-making capacity.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Cs4 supplementation
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. |
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. |
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Komparátor placeba: Matching placebo
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. |
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Forced Expiratory Volume in One Second/ Forced Vital Capacity (FEV1/FVC) ratio
Časové okno: from baseline to week 24
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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. |
from baseline to week 24
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1)
Časové okno: Baseline, week 12, week 24, and week 36
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Change from baseline in FEV1, measured in liters by spirometry according to American Thoracic Society/European Respiratory Society standards. |
Baseline, week 12, week 24, and week 36
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Forced Vital Capacity (FVC)
Časové okno: Baseline, week 12, week 24, and week 36
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Change from baseline in FVC, measured in liters by spirometry according to American Thoracic Society/European Respiratory Society standards. |
Baseline, week 12, week 24, and week 36
|
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Six-Minute Walk Distance (6MWD)
Časové okno: Baseline, week 12, week 24, and week 36
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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. |
Baseline, week 12, week 24, and week 36
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St. George's Respiratory Questionnaire (SGRQ) Total Score
Časové okno: Baseline, week 12, week 24, and week 36
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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. |
Baseline, week 12, week 24, and week 36
|
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Modified Medical Research Council (mMRC) Dyspnea Scale Score
Časové okno: Baseline, week 12, week 24, and week 36
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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. |
Baseline, week 12, week 24, and week 36
|
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Leicester Cough Questionnaire (LCQ) Total Score
Časové okno: Baseline, week 12, week 24, and week 36
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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. |
Baseline, week 12, week 24, and week 36
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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High-Sensitivity C-Reactive Protein (hs-CRP) Level
Časové okno: Baseline, week 24, and week 36
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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. |
Baseline, week 24, and week 36
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Interleukin-6 (IL-6) Level
Časové okno: Baseline, week 24, and week 36
|
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. |
Baseline, week 24, and week 36
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Malondialdehyde (MDA) Level
Časové okno: Baseline, week 24, and week 36
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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. |
Baseline, week 24, and week 36
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Superoxide Dismutase (SOD) Activity
Časové okno: Baseline, week 24, and week 36
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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. |
Baseline, week 24, and week 36
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Glutathione Peroxidase (GPx) Activity
Časové okno: Baseline, week 24, and week 36
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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. |
Baseline, week 24, and week 36
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- UW 26-315
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
Časový rámec sdílení IPD
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.
Kritéria přístupu pro sdílení IPD
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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ANALYTIC_CODE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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