Stomatitis
Conditions
Keywords
oral mucositis, tulsi extract, benzydamine hydrochloride, radiotherapy
Brief summary
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.
Detailed 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
Interventions
DRUGtulsi extract
4% topical oral spray
0.15% topical oral spray
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The principal investigator and participant will be blinded as the treatment preparations will be identical in color, odor, and consistency and they will be placed in identical bottles
Intervention model description
Allocation ratio (1:1)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of mucositis | up to 15 days | Oral Mucositis Assessment Scale (OMAS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain and burning sensation | up to 15 days | assess by numerical rating scale (NRS) (10 points scale) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Oral Assessment Guide (OAG) | up to 15 days | Assessment of patient speech, salivary function and quality, gingival health, swallowing, lips, and oral hygiene. |
| Patient-Reported Oral Mucositis( PROMS scale) | up to 15 days | Quality of life |
Contacts
Primary ContactKarima AbdAllah Kamel, PhD
Outcome results
None listed