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

Официальное название

A Randomized, Waitlist-controlled Clinical Study on the Efficacy and Safety of Lingzhi-containing Dietary Supplement CP003 on Chronic Fatigue and Post-COVID Fatigue

Обзор

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)

Вмешательства

• Препарат LingZhi capsule
  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

Первичные конечные точки

• Mean difference in Chalder Fatigue Score [Срок оценки: From baseline to 6 weeks]

Вторичные конечные точки (6)

• Mean difference in Chalder Fatigue Score [Срок оценки: From baseline to 12 weeks]
• Mean difference in 36-Item Short-Form Health Survey [Срок оценки: from baseline to 6 week and 12 week]
• Mean difference in Fatigue Severity Score [Срок оценки: from baseline to 6 week and 12 week]
• mean difference in (PROMIS) Short Form Fatigue 7A survey [Срок оценки: from baseline to 6 week and 12 week]
• Mean difference in hospital anxiety and depression scale [Срок оценки: from baseline to 6 week and 12 week]
• Mean difference in Pittsburgh sleep quality index [Срок оценки: from baseline to 6 week and 12 week visit.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• Specialist Clinical Centre for Teaching and Research, School of Chinese Medicine, The Univ — Гонконг

Публикации

• Xun Y, Fong TL, Chen G, Feng Y, Chan L, Wang N. Effectiveness and Safety of a Supplement Containing a Pharmacologically Active Basidiomycete Mushroom for Chronic Fatigue and Post-COVID-19 Fatigue Syndrome: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Jan 20;15:e82633. doi: 10.2196/82633. PMID 41558017

Идентификаторы

NCT: NCT06739720 · HKWC-2024-320

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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