Artificial Saliva Containing Cumin and Ginger Extract in Head and Neck Cancer Patients With Xerostomia

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-06-30

Brief Summary

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The objectives of this study are to evaluate efficacy and safety of artificial saliva containing cumin and ginger extract in head and neck cancer patients with xerostomia.

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Detailed Description

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There are 52 patients in this study. They are divided into 2 groups which are artificial saliva containing cumin and ginger extract group (test group) 26 patients and placebo group 26 patients. The patients spray the sample into the mouth 3 times/day for 14 day. Amount of saliva, pH of saliva, xerostomia questionnaires, WHO Oral Mucositis Grading Scale, quality of life, adverse events, and satisfaction were assessed.

Conditions

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Xerostomia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Artificial saliva containing cumin and ginger extract

Artificial saliva containing cumin and ginger extract in spray bottle

Group Type EXPERIMENTAL

Artificial saliva containing cumin and ginger extract

Intervention Type OTHER

Artificial saliva containing cumin and ginger extract in spray bottle

Placebo

Placebo containing composition close to the test group without cumin and ginger extract in spray bottle

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo containing composition close to the test group without cumin and ginger extract in spray bottle

Interventions

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Artificial saliva containing cumin and ginger extract

Artificial saliva containing cumin and ginger extract in spray bottle

Intervention Type OTHER

Placebo

Placebo containing composition close to the test group without cumin and ginger extract in spray bottle

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age more than 18 years
* Head and neck cancer with xerostomia
* 6 months post radiation
* Willing to participate in this study

Exclusion Criteria

* Sialolith or Sjogren's syndrome
* Uncontrolled cancer
* Using artificial saliva more than 2 weeks
* Taking Pilocarpine or cevimeline more than 2 weeks
* Allergic to cumin, ginger, xylitol, and glycerin
* History of other oral mucosal diseases
* Pregnancy and lactation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No