Colorectal cancer
Conditions
Interventions
Intervention group:Sini San granules
Control group:Traditional Chinese Medicine (TCM) placebo
Sponsors
Chongqing University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients with pathologically diagnosed high-risk stage II or III colorectal cancer; PHQ-9 score = 5 or/and GAD-7 score = 5; Completed guideline-recommended conventional Western medical treatment and within = 3 months after treatment completion; No restriction on Traditional Chinese Medicine syndrome type; Aged 18–80 years, regardless of gender; Signed informed consent form.
Exclusion criteria
Exclusion criteria: (1)Presence of local recurrence or distant metastasis. (2) Inability to understand or communicate effectively in Chinese. (3) Diagnosed with severe psychiatric disorders or mental illness. (4) Any unstable condition or factor that may endanger the subject's safety or affect their compliance with the study. (5) Subjects deemed by the investigator to have poor compliance or inability to cooperate and complete the study. (6) History of other malignancies, whether past or concurrent. (7) Participation in another clinical trial within the past month or currently enrolled in another clinical trial and not yet withdrawn. (8) Currently taking other Traditional Chinese Medicine formulations based on syndrome differentiation and treatment principles.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient Health Questionnaire-9 (PHQ-9) score;Generalized Anxiety Disorder 7-item (GAD-7) scale score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI;Traditional Chinese Medicine (TCM) Syndrome Symptom Assessment;;1-2 Year Disease-Free Survival Rate; | — |
Countries
China
Contacts
Public ContactMo Tang
Chongqing University Cancer Hospital
Outcome results
None listed