Fatigue combined with impaired immune function
Conditions
Interventions
Observation group:On top of basic treatment, take Polygonatum and Ginseng tablets orally, 4 tablets per dose, once a day with warm water, continuously for 4 weeks.
Control group:On the basis of basic treatment, take oral placebo, 4 tablets at a time, once a day, with warm water, continuously for 4 weeks.
Sponsors
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Eligibility
Sex/Gender
All
Age
50 Years to 90 Years
Inclusion criteria
Inclusion criteria: (1) Aged 40 years or older, regardless of gender. (2) Meet the diagnostic criteria for qi-deficiency type fatigue combined with immunodeficiency according to both Western and Chinese medicine: · Western medicine diagnostic criteria (meeting any one of the following is sufficient): 1) Whole blood lymphocyte subset test shows NK cell percentage <5%; 2) Whole blood lymphocyte subset test shows an imbalance in cell ratios (refer to "Clinical Flow Cytometry Quality Control Guidelines," considered imbalanced if below 1.2 or above 2.4); 3) Recurrent upper respiratory tract infections within the past year, meeting the adult diagnostic criteria in the "Clinical Concept and Management Principles of Recurrent Respiratory Infections": =6 episodes of upper respiratory infection per year, or =5 episodes per year for 2 consecutive years, with each infection at least 7 days apart, excluding other immunodeficiency diseases. · Chinese medicine diagnostic criteria: Main symptom is fatigue and low energy; secondary symptoms include chest tightness and shortness of breath, sweating upon exertion, poor appetite, low libido, palpitations, dizziness and limb weakness, shortness of breath with reluctance to speak, loose stools, meeting at least 3 of these symptoms; facial complexion is pale, tongue is pale with white or greasy coating and teeth marks on the sides, pulse is deep, thin, and weak. (3) No history of chronic or major diseases, no immunodeficiency. (4) Pre-trial physical examination shows normal liver function indicators in routine check-ups. (5) Voluntary participation in this study, signing the informed consent form, and the ability to cooperate in completing all observation indicator tests and the entire intervention process.
Exclusion criteria
Exclusion criteria: (1) Individuals who cannot take food orally or cannot take the trial medication and placebo as prescribed. (2) Pregnant or breastfeeding women, or those who are intolerant or allergic to the ingredients of Polygonatum and Ginseng tablets or the placebo. (3) Individuals with combined immunodeficiency diseases (such as AIDS, congenital immunodeficiency syndrome, etc.), autoimmune diseases, tumors, or severe diseases involving multiple systems such as the heart, brain, liver, kidneys, and hematopoietic system, as well as patients with mental disorders. (4) Individuals who have taken immunomodulators, glucocorticoids, anti-fatigue health supplements, or traditional Chinese medicine/Chinese patent medicine related to the effects of Polygonatum or Ginseng within a short period (within 1 month before the trial) that may affect result assessment. (5) Individuals who have participated in other clinical trials within the past 3 months. (6) Individuals who refuse to sign the informed consent form or are unable to cooperate to complete the entire study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FS-14 Fatigue Scale Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-Made Traditional Chinese Medicine Qi Deficiency Syndrome Fatigue Score;Fatigue Severity Scale (FSS) Score;Pittsburgh Sleep Quality Index (PSQI) Score;Human Blood Immune Cell Ratio Test;Six-item sex hormone test;Human peripheral blood mononuclear cell transcriptome sequencing;Sequencing of Human Gut Fecal Microbiota and Metabolite Analysis;Human Blood Cytokine Test;Assessment of Hand Microcirculation and Tongue Appearance;Sleep Duration Ratio Monitoring; | — |
Countries
China
Contacts
Public ContactGuiyuan Lv
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Outcome results
None listed