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Clinical Study on the Improvement of Gastrointestinal Reactions Following Postoperative Chemotherapy in Colorectal Cancer by Jiawei Huangqi Xianzhu Formula through Regulation of Gut Microbiota Dysbiosis

Clinical Study on the Improvement of Gastrointestinal Reactions Following Postoperative Chemotherapy in Colorectal Cancer by Jiawei Huangqi Xianzhu Formula through Regulation of Gut Microbiota Dysbiosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001849
Enrollment
Unknown
Registered
2025-09-26
Start date
2025-07-15
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Gastrointestinal Adverse Reactions Following Postoperative Chemotherapy for Colorectal Cancer

Interventions

Intervention group:On the basis of FOLFOX chemotherapy patients in the intervention group will take the modified Huangqi Xianshu formula (comprising Astragalus membranaceus Codonopsis pilosula Poria c
control group:Treatment is administered according to the standard FOLFOX chemotherapy regimen, without the addition of Chinese herbal medicine.

Sponsors

Xiyuan Hospital of CACMS
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 78 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with colorectal cancer who have undergone radical colorectal cancer surgery and are receiving chemotherapy one month postoperatively. Chemotherapy criteria: Stage II high-risk patients (T3N0M0 / pMMR with high-risk factors or T4N0M0) and all Stage III patients (any T N+ M0). 2. No use of microbial preparations (including foods containing lactic acid bacteria etc.) within the past two weeks. 3. No hematological diseases; systemic diseases such as cardiovascular cerebrovascular or metabolic disorders are in a stable condition. 4. Age between 18 and 78 years. 5. Clear consciousness and good compliance with treatment. 6. Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of other malignant tumors or with metastasis. 2. Patients who underwent prophylactic or permanent stoma after surgery. 3. Patients with coexisting gastrointestinal or immune system diseases or severe organ dysfunction. 4. Individuals with specific dietary habits or irregular eating patterns. 5. Pregnant women. 6. Patients with psychiatric disorders. 7. Individuals who cannot tolerate oral Chinese herbal medicine. 8. Patients with incomplete data that may affect the assessment of outcomes or safety or those receiving other related treatments that could influence the study endpoints.

Design outcomes

Primary

MeasureTime frame
GSRS (Gastrointestinal Symptom Rating Scale);

Secondary

MeasureTime frame
Constipation and diarrhea assessment;Quality of life score ;Health status score ;Hematological parameters ;Liver and renal function;Nausea and Vomiting Score;Appetite Score;Cancer-Related Fatigue (CRF) Score;Urinalysis;

Countries

China

Contacts

Public Contactxiezheninan

Xiyuan Hospital of CACMS

xiezhennian@163.com13401185869

Outcome results

None listed

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