Overview

Clinical Study on Prevention Colorectal Adenomatous Polyp Recurrence After Polypectomy Under Colonoscopy by Xiaoai Jiedu Decoction

Status:
Unknown status
Trial end date:
2020-10-18
Target enrollment:
0
Participant gender:
All
Summary
This study evaluates the Xiaoai Jiedu Decoction in Prevention of Colorectal Adenomatous Polyp Recurrence After Colonoscopy.Half of participants will receive Xiaoai Jiedu Decoction,while the other half will receive a placebo.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Jiangsu Famous Medical Technology Co., Ltd.
Criteria
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.