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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-31

Study Completion Date

2024-03-31

Brief Summary

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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.

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Detailed Description

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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

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Stomatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Allocation ratio (1:1)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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

Study Groups

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tulsi extract

4% tulsi extract as intervention

Group Type EXPERIMENTAL

tulsi extract

Intervention Type DRUG

4% topical oral spray

benzydamine hydrochloride

0.15% benzydamine hydrochloride

Group Type ACTIVE_COMPARATOR

Benzydamine Hydrochloride

Intervention Type DRUG

0.15% topical oral spray

Interventions

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tulsi extract

4% topical oral spray

Intervention Type DRUG

Benzydamine Hydrochloride

0.15% topical oral spray

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No