Trials Sponsors Conditions Drugs Pricing

Conditions

Radiation-induced Xerostomia

Keywords

xerostomiagreen teapepprmintMucositis

Outcome Measures

Primary Outcomes (1)

Subjective symptoms of oral dryness
Using a questionnaire will be recorded according to the following: Q1. Does your mouth feel dry? Q2. Do you sip liquids to aid in swallowing dry food? Q3. Does your mouth feel dry when eating a meal? Q4. Does the amount of saliva in your mouth seem to be too little? Subject who answered affirmatively to at least one of the questions related to oral dryness will be considered as positive for subjective complaints of oral dryness. the score range frpm 1-4 according to the number of questions answered by yes
Three points: -"baseline which is at the fourth week of radiotherapy", -"the second point is at seventh week of the radiotherapy, while the end point is after three months of radiotherapy.

Secondary Outcomes (1)

Objective dry mouth score
Three points: -"baseline which is at the fourth week of radiotherapy", -"the second point is at seventh week of the radiotherapy, while the end point is after three months of radiotherapy.

Study Arms (2)

Intervention group:

EXPERIMENTAL

patients in test group will topically apply 20 ml (green tea plus peppermint) (1:1) to the oral mucosa. They will be instructed to keep green tea plus peppermint for at least 5 min duration and then to spit it out. They will be advised to rinse 20 mL of green tea plus peppermint in the same manner before sleeping from fourth week of radiotherapy to three months after radiotherapy.

Dietary Supplement: mix of (green tea and peppermint)

Control group

PLACEBO COMPARATOR

Patients in the control arm will topically apply 20 mL of 0.9% of saline 15 min before and after radiotherapy. They will be advised to rinse saline. They will be instructed to keep saline for at least 5 min duration and then to spit it out. They will be advised to rinse 20 mL of saline in the same manner before sleeping from fourth week of radiotherapy to three months after radiotherapy.

Dietary Supplement: mix of (green tea and peppermint)

Interventions

mix of (green tea and peppermint)Dietary supplement

Dried green tea leaves (100 gm) will be soaked into 500 ml of methanol solution for two days. The solution obtained will then be strained by a strainer and shifted to a glass plate. The plates will be left at room temperature from three to four days. Scraping out of the crystal powder of the extract from the plates will be carried out \[27\]. The peppermint mouth rinse that was used in this study had 1% peppermint base, 10% xylisorb, 5% glycerin, 1% Tween 20%, 5% alcohol 96%, 0/18% methyl paraben, and 0/02% propyl paraben \[28\]. Similarly, green tea plus peppermint mouthwash will be prepared at the same way but by adding 50% green tea leaves and 50% peppermint in the extract.

Control groupIntervention group:

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age20 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Both genders, aged above 20 years.
All patients must have complaint of xerostomia.

Sponsors & Collaborators

Ain Shams University
Otherlead

Study Sites (2)

Ahmed Maher Teaching Hosipital

Cairo, 11565, Egypt

RECRUITING

Fatma E.Sayed A HassaneinCONTACT+201000093885 fatmahassanein@dent.asu.edu.eg

ain shams University

Cairo, 11565, Egypt

COMPLETED

MeSH Terms

Conditions

XerostomiaMucositis

Interventions

Tea

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic DiseasesGastroenteritisGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeverages

Study Officials

dalia Ghalwash
professor
STUDY DIRECTOR

Central Study Contacts

Fatma E.Sayed A Hassanein

CONTACT

+201000093885 fatmahassanein@dent.asu.edu.eg

Asma A. Abou Bakr

CONTACT

Asmaa.Aboubakr@bue.edu.eg

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
Purpose: SUPPORTIVE CARE
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 19, 2024

First Posted

May 16, 2024

Study Start

April 1, 2024

Actual (reported)

Primary Completion

October 2024

Estimated (date passed)

Management of Radiotherapy-related Xerostomia With Green Tea and Peppermint

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Intervention group:

Control group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Intervention group:

Control group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations