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

Stomatitis Clinical Trial

Official title:

The Use of Tulsi Extract for The Management of Oral Mucositis in Head & Neck Cancer Patients Undergoing Radiotherapy: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05323058
• Other study ID #: tulsi in radiation mucositis
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2022
• Est. completion date: March 2024

Study information

• Verified date: May 2022
• Source: Cairo University
• Contact: Karima AbdAllah Kamel, PhD
• Phone: +201014875386
• Email: karima.kamel[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: March 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mucositis
• Stomatitis

Intervention

Drug:
• tulsi extract
4% topical oral spray
• Benzydamine Hydrochloride
0.15% topical oral spray

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oral Assessment Guide (OAG)	Assessment of patient speech, salivary function and quality, gingival health, swallowing, lips, and oral hygiene.	up to 15 days
Other	Patient-Reported Oral Mucositis( PROMS scale)	Quality of life	up to 15 days
Primary	Severity of mucositis	Oral Mucositis Assessment Scale (OMAS)	up to 15 days
Secondary	Pain and burning sensation	assess by numerical rating scale (NRS) (10 points scale)	up to 15 days