RCT of Efficacy and Safety of CP003 on CFS/ME or Post COVID-19 Fatigue
En randomiseret, venteliste-kontrolleret klinisk undersøgelse af effektiviteten og sikkerheden af Lingzhi-holdigt kosttilskud CP003 om kronisk træthed og post-COVID træthed
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)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: TUNG LEONG FONG
- Telefonnummer: +852 5660 4020
- E-mail: tlfong@hku.hk
Undersøgelse Kontakt Backup
- Navn: Yunqing Xun
- Telefonnummer: +852 3917 6515
- E-mail: Windqing@hku.hk
Studiesteder
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-
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Hong Kong, Hong Kong
- Rekruttering
- Specialist Clinical Centre for Teaching and Research, School of Chinese Medicine, The University of Hong Kong
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Kontakt:
- TUNG LEONG FONG
- Telefonnummer: +852 5660 4020
- E-mail: tlfong@hku.hk
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention group
Participants receive CP003 capsules (5 capsules once daily) for 6 weeks, followed by a 6-week follow-up period. |
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 |
|
Ingen indgriben: Waitlist group
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean difference in Chalder Fatigue Score
Tidsramme: From baseline to 6 weeks
|
Likert score 0-4 for 11 items, ranging 0-44, with higher scores indicating greater fatigue |
From baseline to 6 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean difference in Chalder Fatigue Score
Tidsramme: From baseline to 12 weeks
|
Likert score 0-4 for 11 items, ranging 0-44, with higher scores indicating greater fatigue |
From baseline to 12 weeks
|
|
Mean difference in 36-Item Short-Form Health Survey
Tidsramme: from baseline to 6 week and 12 week
|
ranging 0-100, with higher scores indicating better health status |
from baseline to 6 week and 12 week
|
|
Mean difference in Fatigue Severity Score
Tidsramme: from baseline to 6 week and 12 week
|
Likert score 1-7 for 9 items, ranging 9-63, where higher scores indicate more severe fatigue |
from baseline to 6 week and 12 week
|
|
mean difference in Patient Reported Outcome Measurement Information System (PROMIS) Fatigue-Short Form 7A survey
Tidsramme: from baseline to 6 week and 12 week
|
a 5-point Likert scale of 7 items, ranging 0-35, with higher scores indicating greater fatigue |
from baseline to 6 week and 12 week
|
|
Mean difference in hospital anxiety and depression scale
Tidsramme: from baseline to 6 week and 12 week
|
ranging 0-21, with higher scores indicating more severe symptoms |
from baseline to 6 week and 12 week
|
|
Mean difference in Pittsburgh sleep quality index
Tidsramme: from baseline to 6 week and 12 week visit.
|
ranging 0-21, with higher scores indicating worse sleep quality |
from baseline to 6 week and 12 week visit.
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in serum markers
Tidsramme: From baseline to 6 weeks
|
for inflammation, immunity and oxidative aging |
From baseline to 6 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HKWC-2024-320
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
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