Clinical trial · Interventional
The Use of Tulsi Extract for The Management of Oral Mucositis in Head & Neck Cancer Patients Undergoing Radiotherapy
The Use of Tulsi Extract for The Management of Oral Mucositis in Head & Neck Cancer Patients Undergoing Radiotherapy: A Randomized Clinical Trial
NCT05323058CI-TRIAL-00058443unknownPhase 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)
After signing the informed consent, the participant will be allocated to either intervention or control group, then each participant will use either 0.15% benzydamine (Comparator) or 4% tulsi (Intervention) four times a day and also once half an hour before each radiotherapy session.
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 |
|---|---|---|---|
| Stomatitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Benzydamine Hydrochloride | Drug | — | UNRESOLVED |
| tulsi extract | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- tulsi extract
- description
- 4% tulsi extract as intervention
- interventionNames
- Drug: tulsi extract
- type
- ACTIVE_COMPARATOR
- label
- benzydamine hydrochloride
- description
- 0.15% benzydamine hydrochloride
- interventionNames
- Drug: Benzydamine Hydrochloride
Primary outcomes (1)
- measure
- Severity of mucositis
- timeFrame
- up to 15 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients having clinical signs of radiotherapy-induced OM (WHO oral mucositis grading scale: Grade II, III, and IV) * Patient should be able to read and/or understand and sign the consent form. Exclusion Criteria: 1. Patients with HIV infections or hyperthyroidism. 2. Karnofsky performance status (KPS) less than 60% 3. Patients having an allergy to tulsi or benzydamine HCL 4. Patients who are pregnant and/or nursing.
References
Publications (0)
Data not yet available
No reference posted for this study.