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

NCT07320937 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-01-06

No results posted yet for this study

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. 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

Conditions

  • CFS

Interventions

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.

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.

Sponsors & Collaborators

  • ShuGuang Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-29
Primary Completion
2026-08-18
Completion
2026-11-18

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07320937 on ClinicalTrials.gov