Subthreshold depression
Conditions
Interventions
Experimental Group::Wenyang Tiaoti Formula Granules (Composition: Cinnamon 6g/Dried Ginger 10g/Raw Licorice 6g/Jujube 10g/Dioscorea 10g/Lily Bulb 9g/Fennel 6g/Wolfberry 10g/Nutmeg 3g/Raspberry 9g) Adm
Control Group:Placebo Granules (Composition: Maltodextrin + 5% experimental drug extract + Flavoring agents/Colorants) Administration: Same as experimental group.
Sponsors
Li Yingshuai
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for subthreshold depression in Western medicine (DSM-5 criteria not met for depression + CES-D =16 points + 7 = HAMD-17 <17 points) and the diagnostic criteria for yang deficiency constitution in traditional Chinese medicine; 2. Age between 18-65 years old; 3. Residing in Beijing for at least 2 years; 4. Signed an informed consent form.
Exclusion criteria
Exclusion criteria: Patients diagnosed with major depressive disorder (MDD) history of psychiatric disorders or organic mental disorders; Severe hepatic or renal impairment significant cardiac arrhythmias or heart failure; Severe chronic conditions (e.g. diabetes mellitus congestive heart failure); Carriers of viral/bacterial pathogens or patients with infectious diseases; Functional gastrointestinal disorders; Antidepressant therapy within 1 month prior to the trial; Use of antibiotics probiotics/prebiotics or gastrointestinal motility agents within 1 month prior to the trial; Major surgery or significant trauma within 1 month prior to the trial; Occupational exposure to hazardous substances; Night shift work or chronic circadian rhythm disruption; Poor medication adherence or participation in other clinical trials within 1 month; Allergy to trial medications (herbal formula/placebo) known substance dependence or alcohol abuse; Currently breastfeeding pregnant or planning pregnancy within 1 year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 17-item Hamilton Depression Rating Scale;Yang-deficiency Constitution Scale Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Center for Epidemiological Studies Depression Scale (CES-D);Fatigue Scale-14 (FS-14);HAMD - 17 Retardation Factor Score;Serum lactic acid (BLA) content;ATP content;skeletal muscle content;Gut microbiota diversity data;Fecal SCFAs levels;Peripheral blood AMPK, SIRT1, PGC-1a, Nrf1, Nrf2, TFAM protein and mRNA expression levels; | — |
Countries
China
Contacts
Public ContactLi Yingshuai
Beijing University of Chinese Medicine
Outcome results
None listed