drugset / Trial / NCT07543978
Traditional Chinese Medicine for the Prevention of Radiotherapy-Induced Oral Mucositis (RTOM)
Phase 3
Not yet recruiting
156 enrolled
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This is a multicenter, randomized, controlled, prospective clinical trial designed to observe and evaluate the safety and efficacy of Modified Dahuang Huanglian Xiexin Mouthwash for the prevention of radiotherapy-induced oral mucositis (RTOM). Participants will be randomly assigned to receive either the Modified Dahuang Huanglian Xiexin Mouthwash or Placebo Mouthwash. The study aims to assess the preventative effect on RTOM in patients undergoing radiotherapy.
Timeline
- Start
- 2026-04-30
- Primary completion
- 2027-04-30
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Modified Dahuang Huanglian Xiexin Mouthwash | Traditional medicine (herbal / TCM) | 10 ml | Oral |