The Use of Tulsi Extract for The Management of Oral Mucositis in Head & Neck Cancer Patients Undergoing Radiotherapy

Cairo University (CU)

Status and phase: Unknown; Phase 2

Conditions: Stomatitis

Treatments: Drug: Benzydamine Hydrochloride; Drug: tulsi extract

Study type: Interventional

Funder types: Other

Identifiers

NCT05323058

tulsi in radiation mucositis

Details and patient eligibility

About

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.

Full description

the primary outcome is the severity of oral mucositis will assess by Oral Mucositis Assessment Scale (OMAS) and secondary outcomes are pain will assess Numerical rating scale (NRS), Oral Assessment Guide (OAG), and Patient-Reported Oral Mucositis( PROMS scale) All outcomes will be recorded at baseline, and 8, 15 days

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

tulsi extract

Experimental group

Description:

4% tulsi extract as intervention

Treatment:

Drug: tulsi extract

benzydamine hydrochloride

Active Comparator group

Description:

0.15% benzydamine hydrochloride

Treatment:

Drug: Benzydamine Hydrochloride