Colorectal Adenoma
Conditions
Interventions
experimental group:Xihua formula
control group:Deionized Water
Sponsors
Yinchuan Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.The Western medical diagnosis conforms to the diagnostic criteria for colorectal adenoma specified in the Latest Guidelines for Screening, Endoscopic Diagnosis and Treatment of Colorectal Adenoma in China or other authoritative clinical practice guidelines (confirmed by endoscopic examination and pathological biopsy). 2.Adenoma characteristics: single or multiple colorectal adenomas (with an adenoma diameter of =5 mm, or pathological results indicating a villous component of =20%, or complicated with low-grade intraepithelial neoplasia); the patient is inappropriate for or refuses endoscopic resection, or belongs to the population at high risk of postoperative recurrence. 3.Aged 18 to 70 years old (the age shall be calculated based on the date of signing the informed consent form), with no gender restriction. 4.Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with severe complications associated with colorectal adenoma such as toxic megacolon, complete intestinal obstruction, or intestinal perforation; or those with pathologically confirmed malignant transformation (adenocarcinoma) of colorectal adenoma. 2.Pregnant or lactating women, or those planning to become pregnant during the study period and within 6 months after drug discontinuation. 3.Patients complicated with hematopoietic system diseases (e.g., aplastic anemia, leukemia, etc.), severe hepatic insufficiency (Child-Pugh Class C), severe renal insufficiency (Chronic Kidney Disease Stage 4-5, or eGFR <30 ml/min/1.73m²), or other severe organic diseases. 4.Patients with severe mental disorders (e.g., schizophrenia, bipolar disorder, etc.) that are currently uncontrolled, or those unable to cooperate with the completion of study procedures. 5.Patients with a medical history of persistent alcohol or drug abuse within the recent 1 year. 6.Patients currently taking drugs that may affect colorectal mucosal repair or gastrointestinal motility (e.g., long-term use of non-steroidal anti-inflammatory drugs, glucocorticoids, potent antidiarrheal drugs, prokinetic drugs, etc.) and who are unable to meet the washout period requirements after drug discontinuation (the washout period shall be set as 7-14 days or otherwise in accordance with the pharmacokinetic characteristics of the relevant drugs). 7.Patients with a definite history of allergy to the study drug (including its excipients) or relevant foods. 8.Patients currently participating in other drug clinical trials, or those who have participated in other drug clinical trials within the recent 3 months. 9.Patients with contraindications to the study drug (e.g., severe cardiovascular diseases, active infection, etc.; specific contraindications shall be supplemented in accordance with the package insert of the study drug).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target index marker of proliferation Ki-67, proliferating cell nuclear antigen; | — |
Countries
China
Contacts
Public ContactWang Mengyuan
Yinchuan Traditional Chinese Medicine Hospital
Outcome results
None listed