Clinical Trial

Study of Wenyang Tongbi Formula in the Treatment of Chemotherapy-Induced Polyneuropathy

Not Yet Recruiting Early Phase 1
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Summary
This clinical trial aims to evaluate the efficacy of Wenyang Tongbi Granules (a patented Traditional Chinese Medicine prescription) in treating chemotherapy-induced peripheral neuropathy (CIPN). The study compares Wenyang Tongbi Granules with mecobalamin tablets, a standard clinical medication, to determine whether the TCM intervention yields superior outcomes in sensory and motor function of the limbs, as well as overall systemic status, among patients presenting with paresthesia and pain during chemotherapy. Methods: Participants who develop hand-foot paresthesia or pain during chemotherapy will receive either Wenyang Tongbi Granules or mecobalamin tablets daily for a continuous period of 42 days. Evaluations will be conducted on Day 1, Day 21, and Day 42. Outcome measures include the severity and duration of limb paresthesia, as well as changes in TCM-specific syndromes. Additionally, blood samples will be collected to assess variations in serum levels of multiple cytokines, including interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α), before and after the intervention.
Trial Details
NCT Number NCT07626528
Lead Sponsor Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions Chemotherapy-induced Peripheral Neuropathy
Enrollment 144 participants
Start Date 2026-07-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-04