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

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Primary endpoint revisedv5 Show 6 more changesShow less
    • Start date: Nov 21, 2025 to Nov 24, 2025
    • Eligibility criteria expanded, about 68 words
    • Secondary endpoints revised (2)
    • Study description expanded, about 264 words
    • Collaborators expanded, about 53 words
    • Study title expanded, about 4 words
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 10, 2025 to Nov 21, 2025
    v4
  3. Start date: Jul 1, 2025 to Oct 10, 2025v3
  4. Secondary endpoints revised (2)v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
1. Complete a large-sample, multicenter, randomized blank-controlled clinical trial to evaluate Shenling Baizhu Granules for the prevention of colorectal adenoma recurrence. 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. Define the clinical characteristics of patient subgroups most likely to benefit from Shenling Baizhu Granules for preventing colorectal adenoma recurrence.
Trial Details
NCT Number NCT06930157
Lead Sponsor Shanghai Jiao Tong University School of Medicine
Collaborators: Affiliated Hospital of Nanjing University of Chinese Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Sixth Affiliated Hospital, Sun Yat-sen University, Shuguang Hospital of Shanghai University of Traditional Chinese Medicine, Beijing Friendship Hospital, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Institute of Science, Beijing Tongrentang Co., Ltd.
Conditions
(from sponsor)		 Low-risk Colorectal Adenoma
Enrollment 624 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov