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Investigation on the effect of a Chinese herbal formula on intestinal flora and immune function based on spleen deficiency syndrome in patients with colorectal cancer after chemotherapy: Protocol for a randomized controlled trial

Investigation on the effect of a Chinese herbal formula on intestinal flora and immune function based on spleen deficiency syndrome in patients with colorectal cancer after chemotherapy: Protocol for a randomized controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067389
Enrollment
Unknown
Registered
2023-01-06
Start date
2023-01-16
Completion date
Unknown
Last updated
2023-05-15

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 A:Chemotherapy + probiotics
Control group B:Chemotherapy + Chinese Medicine
Treatment group:Chemotherapy + probiotics + Chinese medicine

Sponsors

Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Province Hospital of Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Postoperative colon or rectal cancer; Stage ?-? (TNM stage); 2. Age 18-70 years old; 3. BMI: 18.5-23.9 years; 4. For those eligible for chemotherapy, the expected survival time is more than 3 months; 5. In line with the TCM syndrome of spleen and stomach deficiency; 6. Live locally both 6 months before enrollment and during the medication period after enrollment; 7. Participate voluntarily and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Previous or combined history of other malignant tumors; 2. A history of long-term enteritis (ulcerative colitis, Crohn's disease, multiple intestinal polyps, etc.), a history of chronic constipation, diarrhea, and a genetic bowel history; 3. There are serious respiratory, urinary, cardiovascular, rheumatic immune, nervous system and metabolic diseases, there are serious digestive diseases except intestinal diseases; 4. Malabsorption syndrome or other diseases affecting gastrointestinal absorption, or active peptic ulcer disease; 5. Patients who are allergic to known components of Chinese medicine used in the study; 6. Pregnant women, lactating women and women with family planning, mental patients; 7. Use of micro-ecological regulators or gastric modynamics drugs within 1 month, use of Chinese medicine preparations or antibiotics within the last 2 weeks.

Design outcomes

Primary

MeasureTime frame
Intestinal microbiota detection;TCM symptom score and efficacy evaluation;

Secondary

MeasureTime frame
Quality of life score;Determination of fecal SIgA content;Detection of immune indicators;

Countries

China

Contacts

Public ContactChaolin Zhu

Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Province Hospital of Chinese Medicine)

zhu_chaolin@sina.com+86 133 8276 5963

Outcome results

None listed

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