Clinical trial · Interventional
Evaluation the Effects of Herbal Gargle for Chemoradiotherapy-induced Oral Mucositis of Head & Neck Cancer, a Pilot Study.
NCT05341206CI-TRIAL-00057974unknownPhase 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)
The aim of the study is to evaluate the effects of Herbal gargle on chemoradiotherapy-induced stomatitis in head \& neck cancer patients.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemoradiotherapy | — | UNRESOLVED | — |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Stomatitis and Ulceration | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Herbal gargle | Drug | — | UNRESOLVED |
| Normal saline | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- The treatment group receive Herbal gargle 150ml and are instructed to hold the gargle in the mouth for 30s and then expectorate it twice a day, 5 days a week for 8 weeks.
- interventionNames
- Drug: Herbal gargle
- type
- SHAM_COMPARATOR
- label
- Control group
- description
- The control group receive Normal saline 150ml and are instructed to hold the normal saline in the mouth for 30s and then expectorate it twice a day, 5 days a week for 8 weeks.
- interventionNames
- Other: Normal saline
Primary outcomes (1)
- measure
- Change of CTCAE 4.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Willing to join the trial project and sign the informed consent form. * Age more than 20 years-old. * Pathology proved to be head and neck cancers. * Head and neck cancer patients under radiotherapy or concurrent chemoradiotherapy. * Expected life expectancy more than 3 months. * Subjects with clear consciousness and can be assessed cooperatively. * Subjects are suitable to use Herbal gargle evaluated by Traditional Chinese medicine physicians. Exclusion Criteria: * Subjects can not sing the informed consent form. * Systemic infection. * Heart, liver and kidney insufficiency * Allergy history of Traditional Chinese medicine * Unclear conscious to use Herbal gargle.
References
Publications (0)
Data not yet available
No reference posted for this study.