Multi-center Randomized Controlled Clinical Study of Shenling Baishu Granule to Prevent the Recurrence of Low-risk Colorectal Adenoma

NCT06930157 | Recruiting Phase 4 DMC

• 1 other identifier: KY2024-191-C
• Study Type: interventional
• Target: 624
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Complete a large-sample, multicenter, randomized blank-controlled clinical trial to evaluate Shenling Baizhu Granules for the prevention of colorectal adenoma recurrence.
2. 2.Generate high-level, internationally recognized clinical evidence to support the development of clinical practice guidelines for the prevention and treatment of colorectal adenoma using traditional Chinese medicine, and to strengthen the recommendation level of Shenling Baizhu Granules in clinical guidelines.
3. 3.Define the clinical characteristics of patient subgroups most likely to benefit from Shenling Baizhu Granules for preventing colorectal adenoma recurrence.

Conditions

Low-risk Colorectal Adenoma

Outcome Measures

Primary Outcomes (1)

• Incidence of metachronous low-risk adenomas within 3 years after first dose

  The incidence of metachronous low-risk adenomas will be calculated for each group as the number of participants with metachronous low-risk adenomas detected on surveillance colonoscopy within 3 years of enrollment divided by the total number of participants in that group.

  At 3 years after enrollment

Secondary Outcomes (2)

• Colorectal adenoma progression rate

  At 3 years after enrollment

• TCM syndrome score

  At baseline, 6 months, and 36 months

Study Arms (2)

Experimental Group (Shenling Baizhu Granules)

EXPERIMENTAL

Participants will take Shenling Baizhu granules (6 g, three times daily) for 6 months, started within 3 months after standard endoscopic treatment, in addition to basic health education.

Drug: Shenling Baizhu granules (TCM patent medicine)

Control Group (No intervention)

NO INTERVENTION

Participants will receive only basic health education without taking Shenling Baizhu granules.

Interventions

Shenling Baizhu granules (TCM patent medicine) DRUG

Shenling Baizhu granules is a traditional Chinese medicine preparation in granular form. Participants in the experimental group will take 6 g orally three times daily for 6 months, initiated within 3 months after baseline endoscopic resection and health education. The granules should be taken before meals or at the same time as eating. The granules contain multiple Chinese herbs including Ginseng, Poria, Atractylodes macrocephala, and other traditional ingredients. This formulation is standardized according to Chinese pharmacopoeia standards and is manufactured under GMP conditions. This intervention is being tested for its ability to prevent the recurrence of low-risk colorectal adenomas after endoscopic resection.

Experimental Group (Shenling Baizhu 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:

• Meets the diagnostic criteria for low-risk colorectal adenoma.
• Has undergone a colonoscopy of adequate quality (adequate bowel preparation, cecal intubation achieved, and withdrawal time ≥6 minutes) and received endoscopic minimally invasive polypectomy.
• Within 3 months after adenoma resection.
• years of age; any sex.
• Willing to participate and has voluntarily provided written informed consent.

You may not qualify if:

• Incomplete adenoma resection.
• Long-term use of aspirin, folic acid, calcium supplements, vitamin D, or similar agents.
• Known hereditary polyposis syndromes (e.g., familial adenomatous polyposis) or hereditary colorectal cancer syndromes (e.g., Lynch syndrome/hereditary nonpolyposis colorectal cancer).
• Colonoscopy findings strongly suggestive of inflammatory bowel disease.
• History of malignancy within the past 5 years.
• Pregnant or breastfeeding women, or participants with pregnancy potential who are planning pregnancy.
• Severe cardiovascular or cerebrovascular disease, hepatic or renal insufficiency, or diabetes mellitus.
• Severe psychiatric disorders that would preclude cooperation with colonoscopy procedures.
• Current condition preventing oral administration of the study drug (e.g., dysphagia, chronic diarrhea, intestinal obstruction).
• Participation in another clinical study within the past 3 months or current participation in another clinical study.
• Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Affiliated Hospital of Nanjing University of Chinese Medicine: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Sixth Affiliated Hospital, Sun Yat-sen University: collaborator
• Shuguang Hospital of Shanghai University of Traditional Chinese Medicine: collaborator
• Beijing Friendship Hospital: collaborator
• Yueyang Hospital of Integrated Traditional Chinese and Western Medicine: collaborator
• Institute of Science, Beijing Tongrentang Co., Ltd.: collaborator

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Central Study Contacts

Xiaobo Li

CONTACT

+86021-58752345; lxb_1969@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 16, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)