Artificial Saliva Containing Cumin and Ginger Extract in Head and Neck Cancer Patients With Xerostomia
Efficacy and Safety of Artificial Saliva Containing Cumin and Ginger Extract in Head and Neck Cancer Patients With Xerostomia
1 other identifier
interventional
52
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2023
CompletedFirst Posted
Study publicly available on registry
May 24, 2023
CompletedStudy Start
First participant enrolled
July 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedJune 24, 2024
June 1, 2024
11 months
May 11, 2023
June 21, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Amount of saliva
Spit saliva to the bottle for 5 min
14 days
Secondary Outcomes (8)
Acid and base characteristic of saliva
14 days
Xerostomia questionnaires
14 days
Oral Mucositis Grading Scale
14 days
Adverse reaction: Skin reaction
14 days
Adverse reaction: Respiratory reaction
14 days
- +3 more secondary outcomes
Study Arms (2)
Artificial saliva containing cumin and ginger extract
EXPERIMENTALArtificial saliva containing cumin and ginger extract in spray bottle
Placebo
PLACEBO COMPARATORPlacebo containing composition close to the test group without cumin and ginger extract in spray bottle
Interventions
Artificial saliva containing cumin and ginger extract in spray bottle
Placebo containing composition close to the test group without cumin and ginger extract in spray bottle
Eligibility Criteria
You may qualify if:
- Age more than 18 years
- Head and neck cancer with xerostomia
- months post radiation
- Willing to participate in this study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pornanong Aramwit, Professor
Chulalongkorn University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 11, 2023
First Posted
May 24, 2023
Study Start
July 1, 2024
Primary Completion
May 30, 2025
Study Completion
June 30, 2025
Last Updated
June 24, 2024
Record last verified: 2024-06