Authors
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Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital -More
Category
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Primary study
Registry of Trials»International Traditional Medicine Clinical Trial Registry
Year
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2026
INTERVENTION: Experimental Group:Compound Ejiao Extract (Specification: 20ml per vial), Dosage and Administration: Oral administration, 20ml per dose, three times daily; start on the first day of chemotherapy.;Control Group:Compound Ejiao Oral Liquid Simulator (Specification: 20ml per bottle), Dosage and Administration: Oral, 20ml per dose, three times daily; to be started on the first day of chemotherapy.; CONDITION: Cancer‐related fatigue PRIMARY OUTCOME: The mean score change from baseline of the Piper Fatigue Revised Scale during treatment from 1 week to 6 weeks.; SECONDARY OUTCOME: Changes in FACT‐F scale scores after 3 weeks and 6 weeks of treatment compared to baseline.;Change in BFI scores from baseline at week 3 and week 6 of treatment.;Change in hemoglobin (HGB) from baseline at 3 and 6 weeks of treatment.;The changes in Chinese Medicine (CM) symptom total scores and individual symptom scores after 3 weeks and 6 weeks of treatment compared to baseline values.;Grip strength change from baseline at 3 and 6 weeks of treatment.;Adverse Events ;Vital Signs (Temperature, Pulse, Respiration, Blood Pressure);Physical Examination (Skin and Mucous Membranes, Lymph Nodes, Head and Neck, Chest, Abdomen, Spine/Limbs/Joints, Nervous System, Other Areas).;Laboratory Tests 1) Blood Routine (RBC, WBC, NEUT, HGB, HCT, PLT); 2) Urinalysis (PRO, GLU) + Microscopic Examination of Sediment (LEU, ERY); 3) Liver Function (ALT, AST, ALP, DBIL, TBIL, Y‐GT, ALB); 4) Renal Function (Scr, UreaBUN);;12‐lead electrocardiogram; INCLUSION CRITERIA: (1)18 years = age = 75 years, gender; (2)Confirmed pathological diagnosis of gastric cancer or colorectal cancer, with ECOG PS < 2 points; (3)Gastric cancer or colorectal cancer pTNM stage II or III; (4)Have undergone tumor resection surgery, have completed 2 cycles of adjuvant chemotherapy after surgery, and are assessed by an oncologist to require at least =2 more cycles of adjuvant chemotherapy; (5) Meet the diagnostic criteria for cancer‐related fatigue in Western medicine, with an average score =4 on the Piper Fatigue Revised Scale at screening; (6)Meet the diagnostic criteria for deficiency of both qi and blood in traditional Chinese medicine; (7)Main laboratory examination indicators meet the following conditions: 1) Blood routine: WBC = 3.0x10^9/L or NEUT = 1.5x10^9/L, HGB = 100 g/L, PLT = 100.0x10^9/L; 2) Liver function: TBIL = 1.5xULN, AST and ALT = 2.5xULN, and ALP = 3xULN; ALB = 3 g/dL; 3) INR = 1.5xULN, PT = 1.5xULN,
Epistemonikos ID: 494d6b40309297d7a79f4313ce6c8371b4a9bee0
First added on: Aug 08, 2026