Colorectal adenoma
Conditions
Interventions
Research Group:Endoscopic adenoma resection combined with Wuling Seven-Flavor Hua Xi decoction treatment (1 packet per dose, dissolved in 100 mL of warm water, twice daily).
Control Group:Endoscopic resection only
Sponsors
Zhejiang University of Traditional Chinese Medicine Affiliated Second Hospital (Zhejiang Province Xinhua Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age Range: Participants must be between 18 and 75 years of age, with no restriction on gender. 2) Clear Diagnosis: Confirmed diagnosis of CRA through endoscopic examination and pathological confirmation, with lesions suitable for endoscopic resection. 3) Treatment Preference: Patients willing to undergo endoscopic resection and agree to be randomly assigned to either the control group or the integrated traditional Chinese and Western medicine group. 4) Follow-up Conditions: Patients must be able to complete at least 24 months of follow-up and agree to regular endoscopic examinations. 5) Informed Consent: Patients or their legal representatives have signed the informed consent form, understanding the purpose, methods, potential risks, and benefits of the study and voluntarily participating in the research.
Exclusion criteria
Exclusion criteria: 1) Severe comorbidities: Patients with severe heart, lung, liver, or kidney dysfunction or other systemic diseases. 2) Other gastrointestinal diseases: Patients with inflammatory bowel disease or other chronic gastrointestinal diseases. 3) Drug use: Patients who have used medications that may affect the recurrence rate of CRA within the past 3 months, such as nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin. 4) Surgical history: Patients who have undergone colorectal surgery or endoscopic resection. 5) Intolerance to endoscopic examination: Patients who are unable to tolerate endoscopic examination or endoscopic resection due to physical condition or other reasons. 6) Pregnancy or breastfeeding: Pregnant or breastfeeding women, or patients planning to become pregnant during the study period. 7) Mental or cognitive disorders: Patients with mental or cognitive disorders who are unable to understand the study content or sign the informed consent form. 8) Participation in other studies: Patients participating in other clinical trials that may affect the results of this study. 9) Life expectancy: Patients with a life expectancy of less than 2 years, making it impossible to complete the study follow-up. 10) Allergy history: Patients allergic to Wuling Qwei Huixi Decoction or its components, or allergic to medications used during endoscopic examination. 11) Other contraindications: Patients with contraindications for endoscopic resection, such as severe coagulation disorders or active acute inflammatory bowel disease. 12) Other malignant tumors: Patients diagnosed with other malignant tumors within the past 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adenoma recurrence rate;Clinical Symptom Improvement Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Endoscopic characteristic indicators;Pathological indicators;Traditional Chinese Medicine Syndrome Criteria;Inflammatory markers;Gut microbiota indices;Quality of Life Indicator;Treatment Adherence Index;Cost-effectiveness ratio; | — |
Countries
People's Republic of China
Contacts
Public ContactZhang Wei
Zhejiang University of Traditional Chinese Medicine Affiliated Second Hospital (Zhejiang Xinhua Hospital)
Outcome results
None listed