XerostomiaNCT05872464
Artificial Saliva Containing Cumin and Ginger Extract in Head and Neck Cancer Patients With Xerostomia
A study testing Artificial saliva containing cumin and ginger extract in people with Xerostomia, run by Chulalongkorn University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia
- What is being tested?
- Artificial saliva containing cumin and ginger extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18 years
- Head and neck cancer with xerostomia
- 6 months post radiation
- Willing to participate in this study
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Artificial Saliva Containing Cumin and Ginger Extract in Head and Neck Cancer Patients With Xerostomia
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.
Read the 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.
- Conditions
- Xerostomia
- Being tested
- Artificial saliva containing cumin and ginger extract, Placebo
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial saliva containing cumin and ginger extractOther
Artificial saliva containing cumin and ginger extract in spray bottle
PlaceboOther
Placebo containing composition close to the test group without cumin and ginger extract in spray bottle
| Study group | Role | What they receive |
|---|---|---|
| Artificial saliva containing cumin and ginger extract | Experimental | Artificial saliva containing cumin and ginger extract in spray bottle Receives: Other: Artificial saliva containing cumin and ginger extract |
| Placebo | Placebo comparator | Placebo containing composition close to the test group without cumin and ginger extract in spray bottle Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of saliva
Spit saliva to the bottle for 5 min
Measured: 14 days
Secondary outcomes (8)
Acid and base characteristic of saliva
Spit saliva to the bottle, then take 1 piece of pH strip and dip it into the saliva for 30 seconds. Compare the color of the dipped pH strip to the color chart on pH strip box. The result shows value at pH 1-14.
Measured: 14 days
Xerostomia questionnaires
Assessment xerostomia symptom by patient (scoring 1 to 10 point (low to high xerostomia severity)).
Measured: 14 days
Oral Mucositis Grading Scale
Evaluate oral mucosa by physician (scoring 0 to 4 point (none to life-threatening)).
Measured: 14 days
Adverse reaction: Skin reaction
Found or not found
Measured: 14 days
Adverse reaction: Respiratory reaction
Found or not found
Measured: 14 days
Adverse reaction: Gastrointestinal trat reaction
Found or not found
Measured: 14 days
Quality of life of the patient
Assessment quality of life by patient (scoring 1 to 120 point (high to low quality of life)).
Measured: 14 days
Satisfaction of the patient
Assessment satisfaction by patient (scoring 1 to 10 point (low to high satisfaction)).
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Jul 2024 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
- Investigators
- Pornanong Aramwit, Professor, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872464
- Sponsor's protocol ID
- R177h/66
- Status last verified
- Jun 2024
- First submitted
- 11 May 2023
- Last updated
- 24 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Artificial Saliva Containing Cumin and Ginger Extract in Head and Neck Cancer Patients With Xerostomia
- ClinicalTrials.gov ID
- NCT05872464
- Acronym / sponsor ID
- R177h/66
- Conditions
- Xerostomia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artificial saliva containing cumin and ginger extract | Experimental | Other: Artificial saliva containing cumin and ginger extractArtificial saliva containing cumin and ginger extract in spray bottle |
| Placebo | Placebo comparator | Other: PlaceboPlacebo containing composition close to the test group without cumin and ginger extract in spray bottle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age more than 18 years
- Head and neck cancer with xerostomia
- 6 months post radiation
- Willing to participate in this study
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial saliva containing cumin and ginger extractArtificial saliva containing cumin and ginger extract in spray bottle | Other | Artificial saliva containing cumin and ginger extract |
| PlaceboPlacebo containing composition close to the test group without cumin and ginger extract in spray bottle | Other | Placebo |
Primary outcome
Amount of saliva
Time frame: 14 days
Spit saliva to the bottle for 5 min
8 secondary outcomes
Acid and base characteristic of saliva
Time frame: 14 days
Xerostomia questionnaires
Time frame: 14 days
Oral Mucositis Grading Scale
Time frame: 14 days
Adverse reaction: Skin reaction
Time frame: 14 days
Adverse reaction: Respiratory reaction
Time frame: 14 days
Adverse reaction: Gastrointestinal trat reaction
Time frame: 14 days
Quality of life of the patient
Time frame: 14 days
Satisfaction of the patient
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pornanong Aramwit, Professor principal investigator
Chulalongkorn University
Questions about this trial
What is this clinical trial studying?
A study testing Artificial saliva containing cumin and ginger extract in people with Xerostomia, run by Chulalongkorn University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pornanong Aramwit, Professor (+66899217255, aramwit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of saliva (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.