Optimization of Jianpi Bushen Formula as an In-House Preparation and a New Integrated Traditional Chinese and Western Medicine Treatment Protocol for Translational Research in Adjuvant Therapy for Colorectal Cancer Post-Surgery

Authors
Category Primary study
Registry of TrialsInternational Traditional Medicine Clinical Trial Registry
Year 2026
INTERVENTION: Control Group:Administer adjuvant chemotherapy using the FOLFO Xregimen.;Probiotic group:In addition to the chemotherapy in the control group, Bifidobacterium triple live bacteria capsules were additionally administered.;Original Formula Group:In addition to the chemotherapy in the control group, Jianpi Bushen Decoction was administered.;New dosage form group:In addition to the chemotherapy of the control group, Jianpi Bushen Formula optimized granules were administered.; CONDITION: Colorectal cancer PRIMARY OUTCOME: Cancer‐related fatigue relief rate;Improvement rate of anorexia symptoms;Cumulative recurrence metastasis rate;The overall effective rate of therapeutic effects on the syndrome of Spleen‐Kidney Deficiency; SECONDARY OUTCOME: Disease‐free survival rate;Progression‐Free Survival;Incidence rate of adverse reactions to chemotherapy;Patient quality of life achievement rate;Adherence to New Dosage Form Treatment; INCLUSION CRITERIA: The patient meets the Western medical diagnostic criteria for colorectal cancer (including colon cancer and rectal cancer) and is a stage II‐III colorectal cancer patient within 1 month after surgery; The patient meets the diagnostic criteria for "Spleen‐Kidney Deficiency Syndrome" in Traditional Chinese Medicine; The patient is aged 18‐75 years, with no restriction on gender; The patient has a Karnofsky Performance Status (KPS) score of =70; The patient voluntarily participates in this study and has signed the informed consent form.
Epistemonikos ID: 2dfca69e594cbf5f20b1c99e73c3089bb4e77eb8
First added on: May 09, 2026