A Randomized Clinical Trial of Shenbai Granules in Reducing Recurrence of Colorectal Adenoma

NCT03616444 | Completed Phase 2 DMC

• 1 other identifier: 2017YFC1700602
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroenterology

Keywords

colorectal adenoma; Clinical curative effect; Complementary and alternative medicine

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate

  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.

  2 years

Secondary Outcomes (3)

• The detection rate of any polypoid lesions

  2 years

• The detection rate of high-risk adenomas

  2 years

• The detection rate of sessile serrated lesions

  2 years

Study Arms (2)

TCM-Shenbai Granules

EXPERIMENTAL

Shenbai Granules: Hedyotis diffusa 10g, Sophorae flavescentis radix 4.5g, Codonopsis radix 7.5g, Atractylodis macrocephalae rhizoma 6g, Mume fructus 4.5g, Coptidis rhizoma 1.5g, Zingiberis rhizome praeparatum 3g, Coicis semen 10g. Orally, 1 sachet once, diluted in 150-200 ml of boiling water, 2 times a day.

Drug: Shenbai Granules

TCM-Placebo

PLACEBO COMPARATOR

It contains 5% SBG content, and the remaining ingredients are flavoring agents, starch and coloring agents. It is the same with SBG in appearance, smell and dosage form. Orally, 1 sachet once, diluted in 150-200 ml of boiling water, 2 times a day.

Drug: Shenbai Granules

Interventions

Shenbai Granules DRUG

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.

Also known as: placebo

TCM-Placebo; TCM-Shenbai Granules

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• meet the colorectal adenomatous polyp diagnosis.
• polypectomy under colonoscopy;Including snare polypectomy,endoscopic mucosal resection,endoscopic submucosal dissection.
• aged 18-70.
• sign informed consent.

You may not qualify if:

• colonoscopy was reported, but no pathological findings were found.
• patients with hereditary polyposis.
• there is reliable evidence that the tumor has infiltrated into the intrinsic mucosal layer,or deep infiltration under the mucosa is suspected.
• combined with colorectal malignancy or previous history of colorectal malignancy.
• colonoscopy highly suggests inflammatory bowel disease.
• pregnant and lactating women.
• women who recently have a planning pregnant programme.
• prone to bleeding and using anticoagulants.
• 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.
• unstable vital signs.
• suspect or have a history of alcohol or drug abuse.
• frequent changes in the working environment or other circumstances are likely to cause loss of interview.
• drugs (aspirin, folic acid, vitamin D, calcium) with potential to treat colorectal adenomas have been used.
• those who are participating in other clinical trials.

Sponsors & Collaborators

• Jiangsu Famous Medical Technology Co., Ltd.: lead
• Affiliated Hospital of Nanjing University of Chinese Medicine: collaborator
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator
• Shanghai University of Traditional Chinese Medicine: collaborator
• ShuGuang Hospital: collaborator
• The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine: collaborator
• Changhai Hospital: collaborator
• Beijing Friendship Hospital: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• West China Hospital: collaborator

Study Sites (1)

Affiliated Hospital of Nanjing University of TCM

Nanjing, Jiangsu, 210029, China

Location

Related Publications (1)

• 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.

  PMID: 31374049 DERIVED

Study Officials

• Chen Yugen, PhD

  Key members of the study

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: colorectal adenomatous polyp patients after colonoscopy under colonoscopy

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 6, 2018
• Study Start: December 3, 2018
• Primary Completion: June 28, 2023
• Study Completion: June 28, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)