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A Randomized Controlled Clinical Trial of Sijunzi Decoction Intervention on Nutritional Status in Colorectal Cancer Patients During the Perioperative Period.

Randomized Controlled Clinical Trial of Sijunzi Decoction Intervention on Nutritional Status of Colorectal Cancer Patients in the Perioperative Period.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002346
Enrollment
Unknown
Registered
2025-11-28
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Colorectal cancer

Interventions

Control Group:On the day before surgery, bowel preparation was performed, and the patient was placed on a clear liquid diet. Fasting began at 10:00 PM on the evening before surgery, and the patient wa
Experimental Group:The experimental group, on the basis of the control group's treatment, started taking Sijunzi Decoction (Radix Codonopsis 15g, Poria cocos 15g, Poria cocos 15g, Glycyrrhiza uralensi

Sponsors

Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meets the criteria for colorectal malignant tumors; 2. Age between 18-80 years, gender; 3. Patients (including laparoscopic radical resection for rectal cancer, laparoscopic abdominoperineal resection for rectal cancer, laparoscopic radical resection for sigmoid colon cancer, laparoscopic radical resection for left, and laparoscopic radical resection for right); 4. (PG-SGA score =4 points or serum albumin <35 g/L or BMI <18.5); 5. (according to the TCM symptom survey for colorectal cancer, assessed preoperatively and on the first postoperative day, at least two of the following main symptoms: poor appetite and aversion to food, loose stools, fatigue; and at least one of the following secondary symptoms: abdominal distension, sallow complexion, pale and enlarged tongue with tooth marks or white greasy coating, weak or slow pulse); 6. Self-awareness is clear, able to express normally, and able to communicate without barriers; 7. Patients agree to participate in this clinical study, voluntarily signed the informed consent form, and agree to participate in visits, examinations, and treatments according to the study protocol.

Exclusion criteria

Exclusion criteria: 1)Patients with severe cardiovascular diseases, liver or kidney dysfunction, hematopoietic system disorders, or other severe primary diseases; 2) Patients allergic to the components of this traditional Chinese medicine; 3) Patients with any unstable condition or circumstances that may endanger patient safety or their compliance with the study, such as those with fertility needs, pregnancy, breastfeeding, depression, manic depression, obsessive-compulsive disorder, or schizophrenia and other mental illnesses; 4) Patients with congenital metabolic abnormalities or immunological diseases; 5) Patients with a history of long-term use of drugs affecting gastrointestinal motility (e.g., proton pump inhibitors); 6) Patients deemed unsuitable to participate in this study by the investigator.1.

Design outcomes

Primary

MeasureTime frame
Serum albumin;

Secondary

MeasureTime frame
The time of the patient's first passing of gas and defecation.;Drain Tube Removal Time;Hospital Stay Duration;Postoperative complications;C-reactive protein;white blood cell;Neutrophil;monocyte;Traditional Chinese Medicine Syndrome Scoring Scale;Spleen Qi Deficiency Scale;

Countries

China

Contacts

Public ContactXu Yangxian

Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital

xuyangxian@163.com19921842601

Outcome results

None listed

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