XerostomiaNCT06476223
Artificial Saliva Containing Cumin and Ginger Extract in Hemodialysis Patients With Xerostomia
A study testing Artificial saliva containing cumin and ginger extract in people with Xerostomia, run by Chulalongkorn University.
Trial summary
Hemodialysis patients with xerostomia are divided into 2 groups which are group A (start with artificial saliva containing cumin and ginger extract for 2 weeks, free periods 2 weeks, then placebo for 2 weeks) and group B (start with placebo for 2 weeks, free periods 2 weeks, then artificial saliva containing cumin and… 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
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 31 Jan 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
- Hemodialysis patients with xerostomia (saliva flow rate less than 0.2 g/min)
- Hemodialysed history more than 3 months
- Be willing to participate in the study
Who cannot join
- Patients with sialolith or Sjogren's syndrome
- Uncontrolled other diseases
- Using artificial saliva for more than 2 weeks
- Taking pilocarpine and cevimeline
- Allergic to ginger, cumin, xylitol, and glycerin
- Have mucositis
- Pregnancy or lactation
About this study
Official title: Efficacy and Safety of Artificial Saliva Containing Cumin and Ginger Extract in Hemodialysis
Hemodialysis patients with xerostomia are divided into 2 groups which are group A (start with artificial saliva containing cumin and ginger extract for 2 weeks, free periods 2 weeks, then placebo for 2 weeks) and group B (start with placebo for 2 weeks, free periods 2 weeks, then artificial saliva containing cumin and ginger extract for 2 weeks). Amount of saliva (g/min), xerostomia's questionnaire, Increase of saliva score, World Health Organization Oral Mucositis Grading Scale, acid and base of saliva, quality of life's questionnaire will measure before, after using the sample for 7 and 14 days.
- 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 extractDrug
The sample will be sprayed 2 puff/time, 3 times/day, for 14 days.
PlaceboDrug
The sample will be sprayed 2 puff/time, 3 times/day, for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Artificial saliva containing cumin and ginger extract | Experimental | The sample will be sprayed 2 puff/time, 3 times/day, for 14 days. Receives: Drug: Artificial saliva containing cumin and ginger extract |
| Placebo | Placebo comparator | The sample will be sprayed 2 puff/time, 3 times/day, for 14 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Xerostomia symptoms using Xerostomia Inventory Score
Patients give the score of Xerostomia Inventory questionnaire. The Xerostomia Inventory Score is graded 11 to 55 (Low score means low frequency xerostomia and high score means high frequency of xerostomia)
Measured: 14 days
Secondary outcomes (5)
Salivary flow rate
Weigh the saliva amount from the patients in 5 mins and then calculate in g/min
Measured: 14 days
Amount of saliva score
Patients give the score of saliva amount (0 to 10, 0 means no saliva and 10 means high amount of saliva)
Measured: 14 days
Quality of life score using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35
Patients give the score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35. The score is graded 35 to 130 (Low score means high quality of life and high score means low quality of life)
Measured: 14 days
World Health Organization Oral Mucositis
World Health Organization Oral Mucositis is graded 0 to 4 (0 means no mucositis to 4 means severe mucositis).
Measured: 14 days
Acid and base of saliva
Measure acid and base of saliva using acid and base standard paper
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 posted26 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion31 Jan 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.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476223
- Sponsor's protocol ID
- 0763/66
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2024
- Last updated
- 1 Jul 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 1 Jul 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 Hemodialysis
- ClinicalTrials.gov ID
- NCT06476223
- Acronym / sponsor ID
- 0763/66
- Conditions
- Xerostomia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 26 Jun 2024 (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.
Hemodialysis patients with xerostomia are divided into 2 groups which are group A (start with artificial saliva containing cumin and ginger extract for 2 weeks, free periods 2 weeks, then placebo for 2 weeks) and group B (start with placebo for 2 weeks, free periods 2 weeks, then artificial saliva containing cumin and ginger extract for 2 weeks). Amount of saliva (g/min), xerostomia's questionnaire, Increase of saliva score, World Health Organization Oral Mucositis Grading Scale, acid and base of saliva, quality of life's questionnaire will measure before, after using the sample for 7 and 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artificial saliva containing cumin and ginger extract | Experimental | Drug: Artificial saliva containing cumin and ginger extractThe sample will be sprayed 2 puff/time, 3 times/day, for 14 days. |
| Placebo | Placebo comparator | Drug: PlaceboThe sample will be sprayed 2 puff/time, 3 times/day, for 14 days. |
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
- Hemodialysis patients with xerostomia (saliva flow rate less than 0.2 g/min)
- Hemodialysed history more than 3 months
- Be willing to participate in the study
Key exclusion criteria (7 listed)
- Patients with sialolith or Sjogren's syndrome
- Uncontrolled other diseases
- Using artificial saliva for more than 2 weeks
- Taking pilocarpine and cevimeline
- Allergic to ginger, cumin, 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 extractThe sample will be sprayed 2 puff/time, 3 times/day, for 14 days. | Drug | Artificial saliva containing cumin and ginger extract |
| PlaceboThe sample will be sprayed 2 puff/time, 3 times/day, for 14 days. | Drug | Placebo |
Primary outcome
Xerostomia symptoms using Xerostomia Inventory Score
Time frame: 14 days
Patients give the score of Xerostomia Inventory questionnaire. The Xerostomia Inventory Score is graded 11 to 55 (Low score means low frequency xerostomia and high score means high frequency of xerostomia)
5 secondary outcomes
Salivary flow rate
Time frame: 14 days
Amount of saliva score
Time frame: 14 days
Quality of life score using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35
Time frame: 14 days
World Health Organization Oral Mucositis
Time frame: 14 days
Acid and base of saliva
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 1 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
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 1 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Xerostomia symptoms using Xerostomia Inventory Score (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 1 Jul 2024.