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NCT Number: NCT07320937

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

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

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Key information

Conditions

CFS

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shuguang hospital

Shanghai, Pudong New Area, 201203, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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.

Treatment and study plan

"Yiqi Fuyuan Paste Formula" test group

Other

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 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.

Placebo(a look-alike substance that contains no drug)

Other

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.

Primary outcomes

  1. FAI (Fatigue Assessment Instrument)

    Time frame: week4

Secondary outcomes

  1. SF-36 (The MOS 36-Item Short-Form Health Survey)

    Time frame: week4

  2. QDC（Qi deficiency constitution score）

    Time frame: week4

Other outcomes

  1. inflammatory factors

    Time frame: week 4

    Changes in inflammatory factors(IL-2, IL-6, IL-10, IgA, IgM, INF-γ TNF-α) through peripheral serum

  2. Differential genes

    Time frame: week 4

    Screening of differentially expressed genes through RNA-seq

Sponsors and collaborators

Lead sponsor

ShuGuang Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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