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Набор по приглашению NCT07320937

Effects of Yiqi Fuyuan Paste Formula in Chronic Fatigue Syndrome: A Randomized Double-Blind Controlled Clinical Trial.

Без фазы С лечением CFS

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: "Yiqi Fuyuan Paste Formula" test group, Placebo(a look-alike substance that contains no drug).
Кому может быть актуально
Состояния в реестре: CFS. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Обзор

The goal of this clinical trial is to learn if "Yiqi Fuyuan Paste Formula" (a traditional Chinese medicinal paste made from medicinal and edible Chinese medicines and health food like Ginseng Radix et Rhizoma, Astragali Radix et Rhizoma, Codonopsis Radix, Atractylodis Macrocephalae Rhizoma, Poria Cocos, Coicis Semen, Dioscoreae Rhizoma, Nelumbinis Semen, Angelicae Sinensis Radix, Lycii Fructus, Citri Reticulatae Pericarpium, Juglandis Semen, Longan Arillus, Sesami Nigri Semen, Jujubae Fructus, Glycyrrhizae Radix et Rhizoma, and fine ingredients) works to ease Chronic Fatigue Syndrome (CFS) symptoms in adults. It will also learn about the safety of "Yiqi Fuyuan Paste Formula". The main questions it aims to answer are: 1. Does "Yiqi Fuyuan Paste Formula" help reduce CFS-related fatigue (measured by the Fatigue Assessment Instrument, FAI) 2. What underlying bodily changes (shown in blood tests) might explain its effects. Researchers will compare "Yiqi Fuyuan Paste Formula" to a placebo (a look-alike substance that contains no drug) to see if "Yiqi Fuyuan Paste Formula" works to ease CFS symptoms. Participants will: 1. Take "Yiqi Fuyuan Paste Formula" or a placebo every day for 2 months 2. Visit the clinic before and after the intervention for checkups and tests 3. Keep a diary of their symptoms

Вмешательства

  • Другое "Yiqi Fuyuan Paste Formula" test group
    The intervention is a custom-made herbal paste prepared from food-medicine homology ingredients, including Astragalus membranaceus, Codonopsis pilosula, Dioscorea opposita, and others. It is administered orally twice daily for 12 weeks to improve immune function and quality of life in patients with chronic fatigue or post-illness recovery. Method of taking the ointment: Start taking it from the time it is prepared. It is generally recommended to take it on an empty stomach. The total duration o
  • Другое Placebo(a look-alike substance that contains no drug)
    Method of taking the ointment: Start taking it from the time it is prepared. It is generally recommended to take it on an empty stomach. The total duration of taking it is 8 weeks (20g per dose, twice a day), taking it warm in the morning and evening respectively; The ointment should be stored in the refrigerator for refrigeration.

Первичные конечные точки

  • FAI (Fatigue Assessment Instrument) [Срок оценки: week4]
Вторичные конечные точки (2)
  • SF-36 (The MOS 36-Item Short-Form Health Survey) [Срок оценки: week4]
  • QDC（Qi deficiency constitution score） [Срок оценки: week4]

Критерии участия

Критерии включения

  • Age range: 18 - 65 years old, gender not restricted;
  • Patients meeting the diagnostic criteria for chronic fatigue syndrome;
  • Patients identified as having an "qi deficiency" or "balanced" constitution according to traditional Chinese medicine body type assessment; ④ Voluntary participants who have signed the informed consent form.

Критерии исключения

Those who have any of the following conditions will not be included in this trial.

  • Those with severe depression or other mental disorders, as well as severe diseases of the heart, brain, liver, kidney and hematopoietic system; ② Those who are known to be allergic to the ingredients used in the ointment and have a severe allergic constitution;
  • Women who are currently breastfeeding, pregnant or have the intention to get pregnant during the trial period; ④ Those who are currently participating in other medical clinical trials.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Shuguang hospital — Шанхай

Идентификаторы

NCT: NCT07320937 · 2024-1603-186-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗