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XCHT for Irinotecan-Induced Gut Toxicities (Randomized Controlled Trial)

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated July 1, 2025 (before its estimated June 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Dec 1, 2024 to Jun 1, 2026
    • Study completion date: Feb 1, 2025 to Dec 1, 2026
    v7
  2. Interventions: FOLFIRI/mXELIRI regimen (Drug), Placebo (Drug), Raloxifene (Other), Xiao Chai Hu Tang (XCHT) (Drug) to Irinotecan regimen (Drug), Placebo (Drug), Raloxifene (Other), Xiao Chai Hu Tang (XCHT) (Drug)
    • Eligibility criteria expanded, about 6 words
    • Study description revised
    v6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 15, 2024 to Mar 8, 2024
    • Site details revised
    v5
  4. Start date: Dec 20, 2023 to Jan 15, 2024v4
  5. Start date: Nov 1, 2023 to Dec 20, 2023v3
  6. Start date: Sep 20, 2023 to Nov 1, 2023v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Randomized double-blind placebo-controlled trial (RCT) study, to determine the impact of XCHT on irinotecan-induced severe delayed-onset diarrhea (SDOD), and to determine the feasibility of using plasma raloxifene-4'-glucuronide as a probe for intestinal UGT activity.
Trial Details
NCT Number NCT06055179
Lead Sponsor Guangzhou University of Traditional Chinese Medicine
Collaborators: University of Houston
Conditions
(from sponsor)		 Xiao Chai Hu Tang, Irinotecan-induced Diarrhea
Related terms Neoplasms
Enrollment 98 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov