Chronic Fatigue Syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Preliminary Screening and Inclusion Criteria for Clinical Enrollment Preliminary Screening Criteria for Clinical Enrollment: (1) Informed consent provided by the subjects;(2) Aged 60–70 years, regardless of gender, and right-handed;(3) No dementia, and not meeting the dementia diagnostic criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV);(4) No history of neuropsychiatric diseases (e.g., cerebrovascular disease, epilepsy, Parkinson's disease, multiple sclerosis, encephalitis, depression, schizophrenia, substance dependence, intracranial tumors, craniocerebral trauma surgery, etc.), and no severe diseases of the heart, liver, kidneys, hematopoietic system, or endocrine system that significantly impair cognitive function;(5) Visual and auditory abilities sufficient to meet the requirements of cognitive assessment;(6) No implanted metal or electronic devices. Inclusion Criteria for the Treatment Group: (1) Meeting the above two diagnostic criteria;(2) Primarily presenting with memory impairment or difficulty concentrating, with other cognitive functions relatively intact or mildly impaired;(3) Montreal Cognitive Assessment (MoCA) score < 26;(4) No disease-related treatment received at least 30 days prior to the start of treatment;(5) Clear consciousness, no intellectual disability, stable mood, and ability to cooperate with doctors for diagnosis and treatment;(6) Discontinuation of other treatments that may affect the efficacy evaluation of this study during the trial period. Inclusion Criteria for the Healthy Group: (1) No complaints of cognitive impairment;(2) No functional or organic diseases detected through physical examination;(3) Montreal Cognitive Assessment (MoCA) score = 26, and all results of multidimensional cognitive neuropsychological assessment fall within the normal range corresponding to the subject's age or educational level;(4) No medication taken and no participation in other clinical studies at least 30 days prior to entering the study. Subjects must meet all the above criteria specific to their respective groups to be enrolled.
Exclusion criteria
Exclusion criteria: (1) Those with a history of cerebrovascular diseases, brain parenchymal lesions, and head trauma; (2) Those with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, and hematopoietic systems; (3) Those with progressive malignant tumors or other severe wasting diseases, prone to infections and bleeding; (4) Those with contraindications for MRI examination or claustrophobia; (5) Those who have recently participated in other drug clinical trials. If any one of the above exclusion criteria is met, the subject is not eligible for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Scale Evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Multimodal MRI Data;16S rDNA Sequencing Analysis and Non-targeted Metabolomics Analysis of Feces; | — |
Countries
China
Contacts
Affiliated TCM Hospital of Guangzhou Medical University