Clinical trial · Interventional
Traditional Chinese Medicine Oral Liquids and Mouthwashes for Radiation-induced Oral Mucositis in Head and Neck Cancer Patients
Traditional Chinese Medicine Oral Liquids and Mouthwashes for Radiation-induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Controlled Trial
NCT07282483CI-TRIAL-00106396recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluate the efficacy and safety of traditional Chinese medicine oral liquid and mouthwash in the treatment of radiotherapy induced oral mucositis in patients with head and neck malignancies
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation-induced Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo oral solution and mouthwash | Drug | — | UNRESOLVED |
| Qingying oral liquid and modified Da Huang-Huang Lian Xiexin mouthwash | Drug | — | UNRESOLVED |
| radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Qingying oral liquid and modified Da Huang-Huang Lian Xiexin mouthwash
- interventionNames
- Drug: Qingying oral liquid and modified Da Huang-Huang Lian Xiexin mouthwash
- Radiation: radiotherapy
- type
- PLACEBO_COMPARATOR
- label
- Placebo oral solution and mouthwash
- interventionNames
- Drug: Placebo oral solution and mouthwash
- Radiation: radiotherapy
Primary outcomes (1)
- measure
- Incidence rate of severe oral mucositis (RTOG grade ≥ 3)
- timeFrame
- From the start of radiotherapy to 8 weeks after the end of radiotherapy. The evaluation period is approximately 14 to 14.5 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients pathologically diagnosed with non-metastatic head and neck malignant tumors; 2. Age range: 18 to 65 years old (including 18 and 65 years old); 3. Eastern Cooperative Oncology Group performance status of ≤2; 4. Radiotherapy or concurrent chemoradiotherapy is required; 5. The main organ functions well; 6. Sign informed consent. Exclusion Criteria: 1. Allergic constitution (such as those known to be allergic to two or more drugs); 2. Patients who plan to use drugs that can cause or worsen oral mucosal inflammation (such as anti EGFR monoclonal antibodies, immune checkpoint inhibitors, etc.) after the start of radiotherapy; 3. Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study; 4. Poor oral hygiene and/or severe periodontal diseases; 5. History of head and neck radiotherapy; 6. Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).
References
Publications (0)
Data not yet available
No reference posted for this study.