RCT of Efficacy and Safety of CP003 on CFS/ME or Post COVID-19 Fatigue
만성 피로 및 코로나19 이후 피로에 대한 Lingzhi 함유 건강 보조 식품 CP003의 효능 및 안전성에 관한 무작위 대기자 명단 대조 임상 연구
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)
연구 개요
연구 유형
등록 (추정된)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: TUNG LEONG FONG
- 전화번호: +852 5660 4020
- 이메일: tlfong@hku.hk
연구 연락처 백업
- 이름: Yunqing Xun
- 전화번호: +852 3917 6515
- 이메일: Windqing@hku.hk
연구 장소
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Hong Kong, 홍콩
- 모병
- Specialist Clinical Centre for Teaching and Research, School of Chinese Medicine, The University of Hong Kong
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연락하다:
- TUNG LEONG FONG
- 전화번호: +852 5660 4020
- 이메일: tlfong@hku.hk
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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 |
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간섭 없음: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean difference in Chalder Fatigue Score
기간: From baseline to 6 weeks
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Likert score 0-4 for 11 items, ranging 0-44, with higher scores indicating greater fatigue |
From baseline to 6 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mean difference in Chalder Fatigue Score
기간: From baseline to 12 weeks
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Likert score 0-4 for 11 items, ranging 0-44, with higher scores indicating greater fatigue |
From baseline to 12 weeks
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Mean difference in 36-Item Short-Form Health Survey
기간: from baseline to 6 week and 12 week
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ranging 0-100, with higher scores indicating better health status |
from baseline to 6 week and 12 week
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Mean difference in Fatigue Severity Score
기간: from baseline to 6 week and 12 week
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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
|
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mean difference in Patient Reported Outcome Measurement Information System (PROMIS) Fatigue-Short Form 7A survey
기간: from baseline to 6 week and 12 week
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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
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Mean difference in hospital anxiety and depression scale
기간: from baseline to 6 week and 12 week
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ranging 0-21, with higher scores indicating more severe symptoms |
from baseline to 6 week and 12 week
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Mean difference in Pittsburgh sleep quality index
기간: from baseline to 6 week and 12 week visit.
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ranging 0-21, with higher scores indicating worse sleep quality |
from baseline to 6 week and 12 week visit.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in serum markers
기간: From baseline to 6 weeks
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for inflammation, immunity and oxidative aging |
From baseline to 6 weeks
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .