CFS
Conditions
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. 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
Interventions
OTHERYiqi 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.
OTHERPlacebo(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
ShuGuang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FAI (Fatigue Assessment Instrument) | week4 |
Secondary
| Measure | Time frame |
|---|---|
| SF-36 (The MOS 36-Item Short-Form Health Survey) | week4 |
| QDC（Qi deficiency constitution score） | week4 |
Other
| Measure | Time frame | Description |
|---|---|---|
| inflammatory factors | week 4 | Changes in inflammatory factors(IL-2, IL-6, IL-10, IgA, IgM, INF-γ TNF-α) through peripheral serum |
| Differential genes | week 4 | Screening of differentially expressed genes through RNA-seq |
Countries
China
Outcome results
None listed