Tiaochang Xiaoliu Granules prevent the recurrence of colorectal adenomas: a multi-center, randomized, controlled study
- Conditions
- colorectal adenoma
- Registration Number
- ITMCTR2000003548
- Lead Sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) Patients aged from 40 to 70 years old,either sex;
(2) Patients meets the diagnostic criteria of colorectal adenoma,and the number of adenomas between 1 and 6;
(3) The pathological diagnosis was tubular adenoma, villous adenoma and villous tubular mixed adenoma;
(4) All patients with colorectal adenoma have been treated with endoscopic therapy, and no residual, and within 1 month after surgery.
(5) The subjects were informed and voluntarily signed informed consent.
(1) Patients with colorectal cancer (including early cancer and invasive cancer) or history of colorectal cancer.
(2) Patients with ulcerative colitis, Crohn's disease and other inflammatory bowel diseases.
(3) Women who are pregnant or preparing for pregnancy, a lactating woman.
(4) Patients with severe cardiovascular, pulmonary and cerebrovascular diseases, liver and renal insufficiency (ALT and AST are 2 times higher than the upper limit of normal value in the laboratory of the center; serum creatinine and urea nitrogen are 1.5 times higher than the upper limit of normal value in the laboratory of the center), and can not tolerate colonoscopy treatment and clinical intervention.
(5) Allergic constitution, such as allergic history to two or more drugs or things; or known to be allergic to the ingredients of the drug.
(6) Serious mental illness.
(7) Suspected or confirmed history of alcohol and drug abuse.
(8) Frequent changes in the working environment or other circumstances may easily lead to loss of follow-up.
(9) Drugs (aspirin, folic acid, vitamin D, calcium, etc.) with potential treatment for colorectal adenomas have been used.
(10) Participants in other clinical trials in recent 3 months.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adenoma Detection Rate;
- Secondary Outcome Measures
Name Time Method umber of adenomas;Polyp detection rate;Pathological characteristics of adenoma;Location of adenomas;