Psychosomatic Diseases
Conditions
Interventions
Observation group:Routine treatment + Jieyu Anshen Granules
Control Group:Conventional treatment + Jieyu Anshen granules (equivalent dose of placebo granules)
Sponsors
Beijing University of Chinese Medicine Oriental Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Agree to participate in this trial, sign the informed consent form, comply with relevant trial regulations, take medication on time, and provide biological samples; (2) No restriction on gender, age 18-65 years; (3) Meet the diagnostic criteria for depression and anxiety in DSM-5-TR, diagnosed by a professional psychiatrist as comorbid depression and anxiety, with no severe somatic diseases; (4) HAMD-17 scale score 8-23 points, HAMA-14 scale score 8-28 points, meeting the criteria for mild to moderate anxiety and depression; (5) If taking antidepressant or anti-anxiety medications, limited to the use of selective serotonin reuptake inhibitors (SSRIs) (fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, and escitalopram), or have discontinued antidepressant or anti-anxiety medications for 2 weeks or longer (more than five half-lives of the drug); (6) No use of antibiotics, probiotics, proton pump inhibitors, prokinetic drugs, or nonsteroidal anti-inflammatory drugs in the past month.
Exclusion criteria
Exclusion criteria: 1. Participants with severe anxiety and depression (HAMD-17 = 24 points, HAMA-14 = 29 points); 2. Participants with suicidal tendencies (MADRS suicide item score = 3 points); 3. Participants with a history of schizophrenia or other psychotic disorders, severe depression with psychotic features, bipolar I or II disorder, or severe depression with mixed features; 4. Participants currently taking non-selective 5-hydroxytryptamine reuptake inhibitors for comorbid depression and anxiety, or other prohibited medications (including benzodiazepines, with discontinuation less than 2 weeks or less than 5 half-lives prior to randomization); 5. Participants who have participated in other clinical drug studies (including traditional Chinese medicine, Western medicine, or herbal formulations) within the past month; 6. Participants currently undergoing treatment for depression or anxiety (including but not limited to pharmacotherapy, physical therapy, or psychotherapy); 7. Participants without guardianship, unable to complete the clinical study, or refusing to sign the informed consent form; 8. Pregnant or breastfeeding women; 9. Other situations deemed unsuitable for inclusion by the investigator; 10. Severe abnormalities in liver or kidney function (more than three times the normal average); 11. Participants with a history of allergies or hypersensitivity to the investigational drug; 12. Participants with severe gastric or duodenal diseases affecting drug absorption; 13. Participants with major illnesses (e.g., malignant tumors, severe cardiovascular or cerebrovascular diseases) that may impact the conduct of the study; 14. Participants with clinically significant abnormalities in pre-study laboratory or physical examinations (including vital signs and electrocardiogram), as judged by the investigator, indicating the presence of a physical condition that may hinder participation in the study; 15. Participants who have taken antibiotics, probiotics, proton pump inhibitors, prokinetic agents, or non-steroidal anti-inflammatory drugs within the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery-Asher Depression Rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| 50% reduction rate in MADRS scores before and after treatment;Hamilton Depression Rating Scale-17 Item Version;Hamilton Anxiety Scale-14-item;The changes in medication use during the trial (addition or reduction of routine treatment medications);Three Indices of Heart Rate Variability (Psychological Stress Analysis, Heart Rate Variability Analysis, Time-Frequency Parameters);Traditional Chinese Medicine Constitution Classification and Assessment;Pittsburgh Sleep Quality Index;Quality of Life Scale;TCM Syndrome Score; | — |
Countries
China
Contacts
Public ContactHanZhenyun
Beijing University of Chinese Medicine Oriental Hospital
Outcome results
None listed