NCT05323058

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Stomatitis

Interventions

Type	Name	Description
DRUG	tulsi extract	4% topical oral spray
DRUG	Benzydamine Hydrochloride	0.15% topical oral spray

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-11-01
• Completion: 2024-03-01
• First posted: 2022-04-12
• Last updated: 2022-05-11