Status:
UNKNOWN
The Use of Tulsi Extract for The Management of Oral Mucositis in Head & Neck Cancer Patients Undergoing Radiotherapy
Lead Sponsor:
Cairo University
Conditions:
Stomatitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 (Interve...
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 Gu...
Eligibility Criteria
Inclusion
- 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
- Patients with HIV infections or hyperthyroidism.
- Karnofsky performance status (KPS) less than 60%
- Patients having an allergy to tulsi or benzydamine HCL
- Patients who are pregnant and/or nursing.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05323058
Start Date
July 1 2022
End Date
March 1 2024
Last Update
May 11 2022
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