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

Study Overview

• Status: Enrolling by invitation
• Conditions: CFS
• Intervention / Treatment: Other: Placebo(a look-alike substance that contains no drug); Other: "Yiqi Fuyuan Paste Formula" test group

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Pudong New Area
    • Shanghai, Pudong New Area, China, 201203
      • ShuGuang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo, oral, twice daily for 8 weeks	Other: 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.
Experimental: "Yiqi Fuyuan Paste Formula" test group; Yiqi Fuyuan Paste Formula, oral, twice daily for 8 weeks	Other: "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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
FAI (Fatigue Assessment Instrument)	week4

Secondary Outcome Measures

Outcome Measure	Time Frame
SF-36 (The MOS 36-Item Short-Form Health Survey)	week4
QDC（Qi deficiency constitution score）	week4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
inflammatory factors	Changes in inflammatory factors(IL-2, IL-6, IL-10, IgA, IgM, INF-γ TNF-α) through peripheral serum	week 4
Differential genes	Screening of differentially expressed genes through RNA-seq	week 4

Collaborators and Investigators

• Sponsor: ShuGuang Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 29, 2025
• Primary Completion (Estimated): August 18, 2026
• Study Completion (Estimated): November 18, 2026

Study Registration Dates

• First Submitted: December 21, 2025
• First Submitted That Met QC Criteria: December 21, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 21, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2024-1603-186-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No