Clinical Research Directory
Browse clinical research sites, groups, and studies.
Study of Wenyang Tongbi Formula in the Treatment of Chemotherapy-Induced Polyneuropathy
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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.
Official title: A Multicenter Evidence-Based Clinical Study on the Safety and Efficacy of Wenyang Tongbi Formula in the Treatment of Chemotherapy-Induced Polyneuropathy
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
144
Start Date
2026-07-01
Completion Date
2028-11-01
Last Updated
2026-06-04
Healthy Volunteers
No
Interventions
Wenyang Tongbi Granules and Placebo mecobalamin
Placebo mecobalamin, one capsule per administration, three times daily (tid) with Wenyang Tongbi Granules (10 g/bag), administered as three bags per day for 42 consecutive days
Mecobalamin with placebo Wenyang Tongbi Granules
Mecobalamin (one capsule) administered three times daily (tid), combined with placebo Wenyang Tongbi Granules containing 5% of the original formula concentration (10 g/bag), administered as three bags per day for 42 consecutive days.
Locations (1)
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China