Clinical trial NCT03616444: A Randomized Clinical Trial of Shenbai Granules in Reducing Recurrence of Colorectal Adenoma
Official title: Clinical Evidence-based Evaluation of the Efficacy of Shenbai Granules in Preventing Recurrent Colorectal Adenomas After Polypectomy and Its Therapeutic Mechanism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Gastroenterology
Keywords: colorectal adenoma
Clinical curative effect
Complementary and alternative medicine
Lead sponsor: Jiangsu Famous Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Affiliated Hospital of Nanjing University of Chinese Medicine
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Shanghai University of Traditional Chinese Medicine
name: ShuGuang Hospital
name: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
name: Changhai Hospital
name: Beijing Friendship Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: West China Hospital
First posted: 2018-08-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: colorectal adenomatous polyp patients after colonoscopy under colonoscopy
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Adenoma detection rate
timeFrame: 2 years
Secondary outcomes:
measure: The detection rate of any polypoid lesions
timeFrame: 2 years
measure: The detection rate of high-risk adenomas
timeFrame: 2 years
measure: The detection rate of sessile serrated lesions
timeFrame: 2 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Affiliated Hospital of Nanjing University of TCM
state: Jiangsu
Study officials:
affiliation: Key members of the study
name: Chen Yugen, PhD
role: STUDY_CHAIR
References:
citation: Zhou Q, Chen YG, Xiao J, Chen TT, Liu JR, Zhou W, Li WZ, Wang Y, Zhang BP, Lin J, Meng FD, Gong B, Zheng GY, Han ST, Cheng HB. Traditional Chinese medicine (Xiaoai Jiedu Decoction) as an adjuvant treatment for prevention new colorectal adenomatous polyp occurrence in post-polypectomy: Study protocol for a randomized controlled trial. Medicine (Baltimore). 2019 Aug;98(31):e16680. doi: 10.1097/MD.0000000000016680.