RCT of Efficacy and Safety of CP003 on CFS/ME or Post COVID-19 Fatigue
En randomiserad, väntelista-kontrollerad klinisk studie om effektiviteten och säkerheten av Lingzhi-innehållande kosttillskott CP003 om kronisk trötthet och post-COVID-trötthet
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)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: TUNG LEONG FONG
- Telefonnummer: +852 5660 4020
- E-post: tlfong@hku.hk
Studera Kontakt Backup
- Namn: Yunqing Xun
- Telefonnummer: +852 3917 6515
- E-post: Windqing@hku.hk
Studieorter
-
-
-
Hong Kong, Hong Kong
- Rekrytering
- Specialist Clinical Centre for Teaching and Research, School of Chinese Medicine, The University of Hong Kong
-
Kontakt:
- TUNG LEONG FONG
- Telefonnummer: +852 5660 4020
- E-post: tlfong@hku.hk
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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 |
|
Inget ingripande: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mean difference in Chalder Fatigue Score
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mean difference in Chalder Fatigue Score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in serum markers
Tidsram: From baseline to 6 weeks
|
for inflammation, immunity and oxidative aging |
From baseline to 6 weeks
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HKWC-2024-320
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
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