Gastroenterology
Conditions
Keywords
colorectal adenoma, Clinical curative effect, Complementary and alternative medicine
Brief summary
This study evaluates Shenbai Granules in Prevention of Colorectal Adenomatous Polyp Recurrence After Colonoscopy.Half of participants will receive Shenbai Granules,while the other half will receive a placebo.
Detailed description
There is no internationally recognized standard treatment for the prevention of recurrence of colorectal adenomatous polyps. Based on TCM,previous studies have found that Shenbai Granules can significantly reduce the recurrence and deterioration rate of colorectal adenomatous polyps,reduce the proliferation of tumor cells and promote apoptosis of tumor cells.
Interventions
DRUGShenbai Granules
In the first year, the trial granules will be started after enrollment for 3 months; In the second year, the trial granules will be started in the first 3 months; Each participant should have completed 6 months of trial granules.
Sponsors
Affiliated Hospital of Nanjing University of Chinese Medicine
Guangdong Provincial Hospital of Traditional Chinese Medicine
Shanghai University of Traditional Chinese Medicine
ShuGuang Hospital
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Changhai Hospital
Beijing Friendship Hospital
The First Affiliated Hospital with Nanjing Medical University
West China Hospital
Jiangsu Famous Medical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
A double-blind design is used in this study for the investigators and subjects. The blinding codes are separately sealed and stored by the independent third-party organization. Trial granules are randomly coded as subject unique identification codes, and used by each clinical site according to the assigned drug numbers and in the order of case enrollment. Clinical monitors and investigators must be blinded at all times.
Intervention model description
colorectal adenomatous polyp patients after colonoscopy under colonoscopy
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. meet the colorectal adenomatous polyp diagnosis. 2. polypectomy under colonoscopy;Including snare polypectomy,endoscopic mucosal resection,endoscopic submucosal dissection. 3. aged 18-70. 4. sign informed consent.
Exclusion criteria
1. colonoscopy was reported, but no pathological findings were found. 2. patients with hereditary polyposis. 3. there is reliable evidence that the tumor has infiltrated into the intrinsic mucosal layer,or deep infiltration under the mucosa is suspected. 4. combined with colorectal malignancy or previous history of colorectal malignancy. 5. colonoscopy highly suggests inflammatory bowel disease. 6. pregnant and lactating women. 7. women who recently have a planning pregnant programme. 8. prone to bleeding and using anticoagulants. 9. patients with severe cardiovascular,pulmonary and cerebrovascular diseases and liver and kidney dysfunction (ALT and AST are two 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 the normal value in the laboratory of the center. 10. unstable vital signs. 11. suspect or have a history of alcohol or drug abuse. 12. frequent changes in the working environment or other circumstances are likely to cause loss of interview. 13. drugs (aspirin, folic acid, vitamin D, calcium) with potential to treat colorectal adenomas have been used. 14. those who are participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection rate | 2 years | The ratio of the number of patients with new adenoma detected by colonoscopy to the total number of cases in this group during follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The detection rate of any polypoid lesions | 2 years | The ratio of the number of patients with any polypoid lesions detected by colonoscopy to the total number of cases in this group during follow-up. |
| The detection rate of high-risk adenomas | 2 years | The ratio of the number of patients with high-risk adenomas detected by colonoscopy to the total number of cases in this group during follow-up. |
| The detection rate of sessile serrated lesions | 2 years | The ratio of the number of patients with sessile serrated lesions detected by colonoscopy to the total number of cases in this group during follow-up. |
Countries
China
Outcome results
None listed