Effects of Yiqi Fuyuan Paste Formula in Chronic Fatigue Syndrome: A Randomized Double-Blind Controlled Clinical Trial.
Overview
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- ShuGuang Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- FAI (Fatigue Assessment Instrument)
Overview
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:
- Does "Yiqi Fuyuan Paste Formula" help reduce CFS-related fatigue (measured by the Fatigue Assessment Instrument, FAI)
- 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:
- Take "Yiqi Fuyuan Paste Formula" or a placebo every day for 2 months
- Visit the clinic before and after the intervention for checkups and tests
- Keep a diary of their symptoms
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
FAI (Fatigue Assessment Instrument)
Time Frame: week4
Secondary Outcomes
- SF-36 (The MOS 36-Item Short-Form Health Survey)(week4)
- QDC（Qi deficiency constitution score）(week4)
Investigators
Xiao tian zhang
Director of the Preventive Health Center
ShuGuang Hospital