NCT04261920

Clinical Trial Scheme of Huangqi Guizhi Wuwu Decoction

Study on Efficacy and Safety of Huangqi Guizhi Wuwu Decoction Treatment for Oxaliplatin Induced Peripheral Neurotoxicity: a Protocol for a Randomized, Controlled, Double-blind, Multi-center Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Jiangsu Famous Medical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of Huangqi Guizhi Wuwu decoction in preventing oxaliplatin induced peripheral neurotoxicity.

Detailed description

The purpose of this study is to evaluate whether the preventive effect of Huangqi Guizhi Wuwu decoction on oxaliplatin induced peripheral neurotoxicity is better than that of simulator, and to provide evidence-based medicine basis for the clinical promotion of single medicine granule. This trial purpose is to evaluate the efficacy and safety of Huangqi Guizhi Wuwu decoction in preventing oxaliplatin induced peripheral neurotoxicity. This trial design type is a randomized, controlled, double-blind, multicenter clinical study was conducted.

Conditions

• Oncology

Interventions

Type	Name	Description
DRUG	Huangqi Guizhi Wuwu decoction	The experimental group took Huangqi Guizhi Wuwu decoction twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles). The control group took placebo twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles).

Timeline

• Start date: 2020-01-03
• Primary completion: 2023-01-02
• Completion: 2023-03-02
• First posted: 2020-02-10
• Last updated: 2020-03-09

Locations

2 sites across 1 country: China