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

Cairo University (CU) logo

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

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

Trial contacts and locations

0

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Central trial contact

Karima AbdAllah Kamel, PhD

Data sourced from clinicaltrials.gov

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