Xiaochaihu Granules for Depression After Allogeneic Hematopoietic Stem Cell Transplantation

Inclusion Criteria:

* Participants must meet all of the following criteria:

  1. Able to understand the study procedures and voluntarily provide written informed consent (or consent from a legal guardian where applicable);
  2. Age ≥14 years, male or female;
  3. Patients who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT);
  4. Newly diagnosed depression after allo-HSCT, assessed by standardized scales (e.g., HADS and/or HAMD);
  5. Evidence of successful neutrophil engraftment prior to enrollment;
  6. Willing and able to comply with study procedures and follow-up assessments.

Exclusion Criteria:

1. Refusal to participate in the study;
2. Presence of severe psychiatric disorders or severe somatic symptom disorders;
3. Known allergy to Xiaochaihu Granules or any of its components;
4. Current use of other antidepressant medications;
5. Severe organ dysfunction or unstable clinical condition, including but not limited to:

   Uncontrolled bloodstream infection; Expected survival \<3 months;
6. History of splenectomy;
7. Renal insufficiency with serum creatinine ≥2.0 mg/dL;
8. Cholestatic liver disease or unresolved hepatic veno-occlusive disease (VOD);
9. Significant cardiovascular conditions, including:

   Unstable angina; Acute myocardial infarction within 6 months prior to enrollment; NYHA class III-IV heart failure; Circulatory failure requiring vasoactive or inotropic support; Clinically significant arrhythmia requiring treatment;
10. Severe respiratory disease requiring mechanical ventilation or ≥50% oxygen support;
11. Patients whose primary disease is in complete remission after transplantation (per protocol definition);
12. Participation in another interventional clinical trial within 21 days prior to enrollment (or within 5 half-lives of the investigational product, whichever is longer);
13. Any other condition deemed by the investigator to make the patient unsuitable for participation.