This is a single-center, prospective, randomized, dose-escalation Phase II clinical study. A total of 46 patients with newly diagnosed depression following allogeneic hematopoietic stem cell transplantation (allo-HSCT) will be enrolled. Participants will be randomly assigned to receive different doses of Xiaochaihu Granules in addition to standard post-transplant care for 100 days. The primary objective is to evaluate the efficacy of Xiaochaihu Granules in improving depressive symptoms. Secondary objectives include assessment of safety and clinical outcomes such as event-free survival (EFS), graft-versus-host disease (GVHD), infections, and other transplantation-related complications.
This is a single-center, prospective, randomized, dose-escalation Phase II clinical trial designed to evaluate the efficacy and safety of Xiaochaihu Granules in patients with depression following allogeneic hematopoietic stem cell transplantation (allo-HSCT). A total of 46 eligible patients with newly diagnosed depression after allo-HSCT will be enrolled. Participants will be randomly assigned to receive either a low-dose or high-dose regimen of Xiaochaihu Granules, administered orally twice daily for 100 days, in addition to standard post-transplant care. The primary endpoints include changes in depression severity as assessed by validated scales (e.g., HADS and HAMD) and changes in symptom burden. Secondary endpoints include event-free survival (EFS), incidence of graft-versus-host disease (GVHD), infections, viral reactivation, engraftment outcomes, and overall safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Xiaochaihu Granules 10 g, orally administered twice daily (BID) for 100 days, in addition to standard post-transplant care.
Xiaochaihu Granules 20 g, orally administered twice daily (BID) for 100 days, in addition to standard post-transplant care.
Change in Hospital Anxiety and Depression Scale (HADS) score
Change in HADS total score from baseline to Day 100. The HADS is a validated self-reported scale ranging from 0 to 42, with higher scores indicating more severe anxiety and depression symptoms.
Time frame: Baseline to Day 100
Change in Hamilton Depression Rating Scale (HAMD) score
Change in HAMD score from baseline to Day 100. The HAMD is a clinician-administered scale assessing depression severity, with higher scores indicating more severe depressive symptoms.
Time frame: Baseline to Day 100
Change in Traditional Chinese Medicine (TCM) syndrome score
Change in TCM syndrome score based on a standardized scoring system evaluating symptoms such as appetite, mood, sleep, and somatic complaints. Higher scores indicate more severe syndrome manifestations.
Time frame: Baseline to Day 100
Event-Free Survival (EFS)
Time from treatment initiation to the occurrence of any predefined event, including disease progression, relapse, or death from any cause.
Time frame: Up to Day 100
Incidence of Graft-versus-Host Disease (GVHD)
Incidence of acute or chronic GVHD diagnosed according to standard clinical criteria.
Time frame: Up to Day 100
Incidence of infections
Occurrence of clinically or microbiologically confirmed infections during the study period.
Time frame: Up to Day 100
Cytomegalovirus (CMV) and Epstein-Barr virus (EBV) reactivation
Incidence of CMV or EBV reactivation detected by laboratory testing (e.g., PCR).
Time frame: Up to Day 100
Number of participants with hepatic veno-occlusive disease (VOD) diagnosed according to EBMT criteria
The number of participants who develop hepatic veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) after allo-HSCT, diagnosed according to the European Society for Blood and Marrow Transplantation (EBMT) clinical criteria, including bilirubin elevation, weight gain, hepatomegaly, ascites, or related clinical findings.
Time frame: Up to Day 100 after transplantation
Time to neutrophil and platelet engraftment after allo-HSCT
Neutrophil engraftment is defined as the first of 3 consecutive days with an absolute neutrophil count (ANC) ≥ 0.5 × 10\^9/L without growth factor support. Platelet engraftment is defined as the first of 7 consecutive days with platelet count ≥ 20 × 10\^9/L without platelet transfusion support. Time to engraftment will be calculated from transplantation to the date of engraftment.
Time frame: Up to Day 100 after transplantation
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