Fatigue
Conditions
Interventions
Placebo group:Placebo
Therapy group:Cell Wall-broken Decoction Pieces of Radix Astragali
Sponsors
Guangdong Provincial Hospitai of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.From 18 to 65 years old, regardless of gender; 2.Meets the Fatigue Scale-14 (FS-14) score of = 5 points; 3.Meets the criteria for determining yang deficiency or qi deficiency in Constitution in Chinese Medicine Questionnaire; 4.Understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1:Damp heat constitution and Yin deficiency constitution conversion score = 30 points 2: Sensitive to Radix Astragali 3: Have used other anti fatigue drugs in the past month; 4: Individuals who have suffered from or currently have severe mental illnesses (moderate to severe depression (GAD-7 = 10), moderate to severe anxiety (PHQ-9 = 10), schizophrenia, bipolar disorder, etc.) and require medication for control; 5: Patients who have previously or currently suffered from serious underlying diseases such as cardiovascular, cerebrovascular, lung, liver, kidney, and endocrine system diseases, and whose condition is still unstable while maintaining basic treatment; 6: Patients with a history of malignant tumors 7: Women in the preconception, pregnancy, or lactation period; 8: Individuals who have participated in clinical trials of other drugs within the past 30 days; 9: Researchers believe that individuals who are not suitable for conducting this clinical trial; 10: The subjects who provide samples of gut microbiota also include the following three exclusion criteria: those who take foods or drugs that regulate gut microbiota, such as yogurt, Bifidobacterium triple viable capsules, etc; Those who have used antibiotics in the past three months; Except for those with yang deficiency or qi deficiency, the conversion score of other constitutions is = 30 points.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue Scale-14; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fatigue Self-assessment Scale;Kidney function (BUN, Cr);SF-36;Pittsburgh Sleep Quality Index;CRP(C-reactive protein);Interleukin-6,IL-6;Tumor necrosis factor- a;Constitution in Chinese Medicine Questionnaire;Visual Analogue Scale;Urine routine test;Liver function (AST, ALT);Multi lead electrocardiogram;Blood routine test; | — |
Countries
China
Contacts
Public ContactZhimin Yang
Guangdong Provincial Hospital of Chinese Medicine Dade Road General Hospital
Outcome results
None listed