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The effectiveness and safety of Shengbai oral solution in preventing/treating neutropenia in patients with colorectal cancer undergoing chemotherapy: a randomized, controlled, single-center clinical study

The effectiveness and safety of Shengbai oral solution in preventing/treating neutropenia in patients with colorectal cancer undergoing chemotherapy: a randomized, controlled, single-center clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077280
Enrollment
Unknown
Registered
2023-11-03
Start date
2023-11-06
Completion date
Unknown
Last updated
2023-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

treatment group:After screening, Shengbai oral liquid was taken orally on the same day of chemotherapy, 40mL each time, 3 times a day, for 2 chemotherapy cycles, a total of 42±3 days
observation group :conventional therapy

Sponsors

Department of Digestive Oncology, Civil Aviation General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1: Age =18 years, =75 years, no gender restriction 2: Patients with confirmed diagnosis of colorectal cancer by pathology/cytology 3: Patients who have experienced grade I-III myelosuppression in the past and can continue to receive chemotherapy 4: General condition ECOG score =2 points 5: Laboratory tests basically meet the following requirements:Blood routine: a. absolute neutrophil count (ANC) =1.6×109/L b. platelet count (PLT) =70×109/L;Biochemical testing: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 times the upper limit of normal (ULN);serum creatinine (Cr) =1.5 times the upper limit of normal 6: Expected survival time =3 months 7: Patients voluntarily participated in this clinical trial and signed an informed consent form

Exclusion criteria

Exclusion criteria: 1.Received radiotherapy within 4 weeks prior to enrollment. 2.Received hematopoietic stem cell transplantation or bone marrow transplantation. 3.Currently experiencing severe acute infections that are not under control; or suffering from purulent and chronic infections with non-healing wounds. 4.Previously diagnosed or suspected allergies to the investigational drug or its related components. 5.Concurrently diagnosed with conditions such as splenomegaly, hyperthyroidism, adrenal insufficiency, connective tissue diseases, or infectious diseases like viral hepatitis, tuberculosis, which can cause leukopenia. 6.Uncontrolled gastrointestinal symptoms that would interfere with the intake of the study drug, such as nausea, vomiting, diarrhea, etc. 7.Central nervous system metastasis, accompanied by symptoms. 8.Previously diagnosed with or currently suffering from other malignant tumors, excluding cured basal cell carcinoma of the skin and cervical carcinoma in situ. 9.Patients with severe heart, liver, kidney diseases; serious hematopoietic system disorders; or those prone to bleeding. 10.History of drug abuse that cannot be discontinued; patients with schizophrenia or significant mental disorders with poor compliance. 11.Pregnant or breastfeeding women; or patients capable of reproduction who are unwilling to use contraception. 12.Currently participating in other clinical trials or have participated in other drug clinical trials within the past month.

Design outcomes

Primary

MeasureTime frame
the incidence of neutropenia;

Secondary

MeasureTime frame
incidence and duration of peripheral blood leukopenia;incidence and duration of thrombocytopenia in peripheral blood ;incidence and duration of hemoglobinemia in peripheral blood ;cancer related fatigue;dosage and frequency of rhG-CSF;the number of days and degree of recovery from leukopenia after chemotherapy;

Countries

China

Contacts

Public ContactJianping Cheng

Civil Aviation General Hospital

cjpczy2004@163.com+86 158 1128 2039

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026