Shenbai Granules for Preventing Recurrence of Low-Risk Colorectal Adenomas

NCT07123116 | Not Yet Recruiting DMC

• 1 other identifier: 2025NL-108-02
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Shenbai Granules for Preventing Recurrence of Low-Risk Colorectal Adenomas（LRCRA）. Study Population: Post-resection patients with low-risk colorectal adenomas and Spleen Deficiency with Dampness-Heat Syndrome per TCM criteria. Sample Size: 450 subjects (1:1 randomization; 225 per arm) accounting for ≤20% dropout. Study Hypothesis (Exploratory) ： This exploratory trial aims to evaluate the potential efficacy and safety of Shenbai Granules, a TCM formula, in reducing LRCRA recurrence. Based on preliminary data suggesting a 32.64% relative risk reduction in LRCRA recurrence at 2 years, we hypothesize that Shenbai Granules may demonstrate clinically meaningful prevention of adenoma recurrence and offer a favorable safety profile in the target TCM syndrome population. No formal statistical hypothesis is tested. Statistical Analysis Analysis Sets: mITT (primary efficacy), PPS, SS (safety). Primary Analysis: Proportion difference (Newcombe method) and χ²/Fisher's exact test (stratified CMH if applicable). Sensitivity analyses: PPS, tipping-point imputation for missing data. Safety: Descriptive summaries of AEs/SAEs (MedDRA-coded), lab abnormalities.

Conditions

Colorectal Adenoma; TCM; Low Risk

Outcome Measures

Primary Outcomes (1)

• Detection rate of metachronous colorectal adenoma within 3 years after initial administration.

  the proportion of patients with detected metachronous colorectal adenomas during surveillance colonoscopy performed within 3 years after baseline polypectomy or adenoma resection to the total number of patients in the group.

  3 years

Secondary Outcomes (3)

• Cumulative number, quantity, size, location, and pathology of detected metachronous colorectal adenomas within 3 years after initial administration.

  3 years

• Detection rate of serrated lesions within 3 years after initial administration.

  3 years

• Cumulative number, quantity, size, location, and pathology of detected serrated lesions within 3 years after initial administration.

  3 years

Study Arms (2)

Shenbai Granules

EXPERIMENTAL

Shenbai Granules is a traditional Chinese medicine preparation formulated from eight herbal ingredients, including Sophorae Flavescentis Radix (Kushen), Coptidis Rhizoma (Huanglian), and other herbs. It exerts therapeutic effects by clearing heat and drying dampness, while simultaneously invigorating the spleen and replenishing qi.

Drug: Shenbai Granules

Placebo

PLACEBO COMPARATOR

The placebo was formulated using Shenbai Granules dry extract powder at 2% (w/w) of the equivalent dose found in the compound herbal granules, supplemented with colorants and flavoring agents to ensure visual and gustatory consistency with the Shenbai Granules.

Drug: Placebo

Interventions

Shenbai Granules DRUG

Dosage: bag 10g per , administered twice daily continuously for 180 days.

Shenbai Granules

Placebo DRUG

Dosage: 10g per bag, administered twice daily continuously for 180 days.

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 40-75 years, regardless of sex;
• Patients with histologically confirmed high-risk adenomas undergoing initial polypectomy, with high-quality colonoscopy performed within 14 days before randomization;
• Complete resection of all detected lesions during colonoscopy;
• Meeting TCM diagnostic criteria for spleen deficiency with dampness-heat syndrome;
• Provision of signed informed consent and ability to comply with long-term follow-up.
• High-quality colonoscopy is defined as: Boston Bowel Preparation Scale (BBPS) score ≥6, cecal intubation with photo-documentation and withdrawal time ≥6 minutes. If quality standards cannot be confirmed, a repeat colonoscopy is required.

Sponsors & Collaborators

• Jiangsu Famous Medical Technology Co., Ltd.: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• The Second Hospital of Shandong University: collaborator
• Shengjing Hospital: collaborator
• Shenzhen Hospital of Southern Medical University: collaborator
• Sixth Affiliated Hospital, Sun Yat-sen University: collaborator
• Sichuan Provincial People's Hospital: collaborator
• Shanxi Provincial People's Hospital: collaborator
• Affiliated Hospital of Nanjing University of Chinese Medicine: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator

Study Sites (1)

Affiliated Hospital of Nanjing University of Chinese Medicine

Nanjing, Jiangsu, China

Location

Central Study Contacts

Haibo Cheng, Professor

CONTACT

025-85811001; hbcheng@njucm.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 14, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

CN (1)