Back to resultsThe Use of Tulsi Extract for The Management of Oral Mucositis in Head & Neck Cancer Patients Undergoing Radiotherapy
Primary Purpose
Stomatitis
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
tulsi extract
Benzydamine Hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Stomatitis focused on measuring oral mucositis, tulsi extract, benzydamine hydrochloride, radiotherapy
Eligibility Criteria
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:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
tulsi extract
benzydamine hydrochloride
Arm Description
4% tulsi extract as intervention
0.15% benzydamine hydrochloride
Outcomes
Primary Outcome Measures
Severity of mucositis
Oral Mucositis Assessment Scale (OMAS)
Secondary Outcome Measures
Pain and burning sensation
assess by numerical rating scale (NRS) (10 points scale)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05323058
Brief Title
The Use of Tulsi Extract for The Management of Oral Mucositis in Head & Neck Cancer Patients Undergoing Radiotherapy
Official Title
The Use of Tulsi Extract for The Management of Oral Mucositis in Head & Neck Cancer Patients Undergoing Radiotherapy: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomatitis
Keywords
oral mucositis, tulsi extract, benzydamine hydrochloride, radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Allocation ratio (1:1)
Masking
ParticipantInvestigator
Masking Description
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
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tulsi extract
Arm Type
Experimental
Arm Description
4% tulsi extract as intervention
Arm Title
benzydamine hydrochloride
Arm Type
Active Comparator
Arm Description
0.15% benzydamine hydrochloride
Intervention Type
Drug
Intervention Name(s)
tulsi extract
Intervention Description
4% topical oral spray
Intervention Type
Drug
Intervention Name(s)
Benzydamine Hydrochloride
Intervention Description
0.15% topical oral spray
Primary Outcome Measure Information:
Title
Severity of mucositis
Description
Oral Mucositis Assessment Scale (OMAS)
Time Frame
up to 15 days
Secondary Outcome Measure Information:
Title
Pain and burning sensation
Description
assess by numerical rating scale (NRS) (10 points scale)
Time Frame
up to 15 days
Other Pre-specified Outcome Measures:
Title
Oral Assessment Guide (OAG)
Description
Assessment of patient speech, salivary function and quality, gingival health, swallowing, lips, and oral hygiene.
Time Frame
up to 15 days
Title
Patient-Reported Oral Mucositis( PROMS scale)
Description
Quality of life
Time Frame
up to 15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karima AbdAllah Kamel, PhD
Phone
+201014875386
Email
karima.kamel@dentistry.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Use of Tulsi Extract for The Management of Oral Mucositis in Head & Neck Cancer Patients Undergoing Radiotherapy
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