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Trial Title:
Artificial Saliva Containing Cumin and Ginger Extract in Head and Neck Cancer Patients With Xerostomia
NCT ID:
NCT05872464
Condition:
Xerostomia
Conditions: Official terms:
Head and Neck Neoplasms
Xerostomia
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Artificial saliva containing cumin and ginger extract
Description:
Artificial saliva containing cumin and ginger extract in spray bottle
Arm group label:
Artificial saliva containing cumin and ginger extract
Intervention type:
Other
Intervention name:
Placebo
Description:
Placebo containing composition close to the test group without cumin and ginger extract
in spray bottle
Arm group label:
Placebo
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
July 1, 2024
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Chulalongkorn University
Agency class:
Other
Source:
Chulalongkorn University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05872464
