RCT of Efficacy and Safety of CP003 on CFS/ME or Post-COVID Fatigue

Phase 3Not Yet RecruitingNCT06739720

The University of Hong Kong130 enrolled

Overview

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? Researchers will compare people taking the Lingzhi supplement to those who don't take anything (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 questionnaires for waitlist group)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Chronic Fatigue Syndrome (CFS)Post-COVID ME/CFS

Interventions

Lingzhi-containg 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 sesame extract

Eligibility

Sex: ALLMin age: 40 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Mean difference in Chalder Fatigue Score

Time frame: From baseline to 6 weeks

Secondary Outcomes

Mean difference in Chalder Fatigue Score

Time frame: From baseline to 12 weeks

Mean difference in 36-Item Short-Form Health Survey

Time frame: from baseline to 6 week and 12 week

Mean difference in Fatigue Severity Score

Time frame: from baseline to 6 week and 12 week

mean difference in (PROMIS) Short Form Fatigue 7A survey

Time frame: from baseline to 6 week and 12 week

Mean difference in hospital anxiety and depression scale

Time frame: from baseline to 6 week and 12 week

Mean difference in Pittsburgh sleep quality index

Time frame: from baseline to 6 week and 12 week visit.

RCT of Efficacy and Safety of CP003 on CFS/ME or Post-COVID Fatigue

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts