The Use of Tulsi Extract for The Management of Oral Mucos... | NCT05323058

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

NCT05323058

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

May 11, 2022Actual

Enrollment

42Estimated

Phase

Phase 2

Conditions

Stomatitis

Interventions

tulsi extract
Benzydamine Hydrochloride

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2022Estimated

Primary Completion Date

Nov 2023Estimated

Completion Date

Mar 2024Estimated

First Submitted Date

Mar 27, 2022

First Submission Date that Met QC Criteria

Apr 4, 2022

First Posted Date

Apr 12, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2022

Last Update Posted Date

May 11, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
tulsi extract	Experimental	4% tulsi extract as intervention	Drug: tulsi extract
benzydamine hydrochloride	Active Comparator	0.15% benzydamine hydrochloride	Drug: Benzydamine Hydrochloride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tulsi extract	Drug	4% topical oral spray	tulsi extract
Benzydamine Hydrochloride

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Severity of mucositis	Oral Mucositis Assessment Scale (OMAS)	up to 15 days

Secondary Outcomes

Measure	Description	Time Frame
Pain and burning sensation	assess by numerical rating scale (NRS) (10 points scale)	up to 15 days

Other Outcomes

Measure	Description	Time Frame
Oral Assessment Guide (OAG)	Assessment of patient speech, salivary function and quality, gingival health, swallowing, lips, and oral hygiene.	up to 15 days
Patient-Reported Oral Mucositis( PROMS scale)

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Karima AbdAllah Kamel, PhD	Contact	+201014875386		karima.kamel@dentistry.cu.edu.eg

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013280	Stomatitis

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000713370	holy basil leaf extract
D001591	Benzydamine

Ancestor Terms

ID	Term
D007191	Indazoles
D011720	Pyrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Double

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

Who Masked

ParticipantInvestigator