A Study on the Clinical Efficacy and Mechanism of Effect of Xiaoyaosan in the Treatment of Liver Stagnation and Spleen Deficiency Type Depression

Based on the dysregulation of the brain-gut-microbiota axis mediated by inflammation and mitochondrial damage, this study investigates the biological mechanisms of depression of Liver Qi stagnation and Spleen deficiency type and the intervention mechanisms of Xiaoyaosan.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2026001401

Enrollment

Unknown

Registered

2026-06-03

Start date

2024-07-01

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Interventions

Experimental Group:Xiaoyaosan

Control Group:Traditional Chinese Medicine placebo

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for depression; 2. Meets the syndrome criteria for Liver Qi Stagnation and Spleen Deficiency; 3. 7 points = HAMD (17 items) = 24 points; 4. 18 years = age = 65 years; 5. Voluntarily signed an informed consent form. Patients who meet all of the above 5 criteria are eligible for inclusion.

Exclusion criteria

Exclusion criteria: 1. Participants with a history of using antibiotics within the past 6 weeks; 2. Participants who have used sedative-hypnotic and antidepressant medications for mental disorders in the past month; 3. Participants with drug dependence or alcohol dependence; 4. Participants with severe organic diseases of the heart, brain, liver, or kidneys, or with tumors, endocrine system diseases, or immune system diseases; 5. Participants with mental retardation due to congenital or acquired causes; 6. Participants with depression caused by a clear underlying disease; 7. Pregnant or breastfeeding women. Any participant who meets any of the above criteria will be excluded.

Design outcomes

Primary

Measure	Time frame
Hamilton Depression Rating Scale (17-item);	—

Secondary

Measure	Time frame
Traditional Chinese Medicine Syndrome Scoring Scale;Montgomery-Åsberg Depression Rating Scale;Depression Symptom Elements Assessment Scale;	—

Countries

China

Contacts

Public ContactLi Bao Ling

Shanxi Province Institute of Traditional Chinese Medicine

15934128836@163.com15934128836

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 29, 2026