The Use of Tulsi Extract for The Management of Oral Mucositis in Head & Neck Cancer Patients Undergoing Radiotherapy
1 other identifier
interventional
42
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2022
CompletedFirst Posted
Study publicly available on registry
April 12, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedMay 11, 2022
May 1, 2022
1.3 years
March 27, 2022
May 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Severity of mucositis
Oral Mucositis Assessment Scale (OMAS)
up to 15 days
Secondary Outcomes (1)
Pain and burning sensation
up to 15 days
Other Outcomes (2)
Oral Assessment Guide (OAG)
up to 15 days
Patient-Reported Oral Mucositis( PROMS scale)
up to 15 days
Study Arms (2)
tulsi extract
EXPERIMENTAL4% tulsi extract as intervention
benzydamine hydrochloride
ACTIVE COMPARATOR0.15% benzydamine hydrochloride
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- 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
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
March 27, 2022
First Posted
April 12, 2022
Study Start
July 1, 2022
Primary Completion
November 1, 2023
Study Completion
March 1, 2024
Last Updated
May 11, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share