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

NCT07320937 | Enrolling By Invitation

• 1 other identifier: 2024-1603-186-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Does "Yiqi Fuyuan Paste Formula" help reduce CFS-related fatigue (measured by the Fatigue Assessment Instrument, FAI)
2. 2.What underlying bodily changes (shown in blood tests) might explain its effects.
3. 3.Take "Yiqi Fuyuan Paste Formula" or a placebo every day for 2 months
4. 4.Visit the clinic before and after the intervention for checkups and tests
5. 5.Keep a diary of their symptoms

Conditions

CFS

Outcome Measures

Primary Outcomes (1)

• FAI (Fatigue Assessment Instrument)

  week4

Secondary Outcomes (2)

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

  week4

• QDC（Qi deficiency constitution score）

  week4

Other Outcomes (2)

• inflammatory factors

  week 4

• Differential genes

  week 4

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo, oral, twice daily for 8 weeks

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

"Yiqi Fuyuan Paste Formula" test group

EXPERIMENTAL

Yiqi Fuyuan Paste Formula, oral, twice daily for 8 weeks

Other: "Yiqi Fuyuan Paste Formula" test group

Interventions

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.

Placebo

"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.

"Yiqi Fuyuan Paste Formula" test group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ShuGuang Hospital: lead

Study Sites (1)

Shuguang hospital

Shanghai, Pudong New Area, 201203, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Preventive Health Center

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: January 6, 2026
• Study Start: December 29, 2025
• Primary Completion (Estimated): August 18, 2026
• Study Completion (Estimated): November 18, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)