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Not yet recruitingNCT05872464Updated Jun 24, 2024

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

An interventional study of Artificial saliva containing cumin and ginger extract and Placebo in Xerostomia, sponsored by Chulalongkorn University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-24.

Sponsored by Chulalongkorn University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's planned enrollment of 52 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Chulalongkorn University is the lead sponsor of 312 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
52 participants (estimated)

Study arms

  • Experimental
    Artificial saliva containing cumin and ginger extract

    Artificial saliva containing cumin and ginger extract in spray bottle

    Other: Artificial saliva containing cumin and ginger extract

  • Placebo comparator
    Placebo

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

    Other: Placebo

Interventions

  • OtherArtificial saliva containing cumin and ginger extract

    Artificial saliva containing cumin and ginger extract in spray bottle

  • OtherPlacebo

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

06

What researchers measure

Primary outcomes

  1. Amount of saliva

    Spit saliva to the bottle for 5 min

    Time frame: 14 days

Secondary outcomes

  1. 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.

    Time frame: 14 days

  2. Xerostomia questionnaires

    Assessment xerostomia symptom by patient (scoring 1 to 10 point (low to high xerostomia severity)).

    Time frame: 14 days

  3. Oral Mucositis Grading Scale

    Evaluate oral mucosa by physician (scoring 0 to 4 point (none to life-threatening)).

    Time frame: 14 days

  4. Adverse reaction: Skin reaction

    Found or not found

    Time frame: 14 days

  5. Adverse reaction: Respiratory reaction

    Found or not found

    Time frame: 14 days

  6. Adverse reaction: Gastrointestinal trat reaction

    Found or not found

    Time frame: 14 days

  7. Quality of life of the patient

    Assessment quality of life by patient (scoring 1 to 120 point (high to low quality of life)).

    Time frame: 14 days

  8. Satisfaction of the patient

    Assessment satisfaction by patient (scoring 1 to 10 point (low to high satisfaction)).

    Time frame: 14 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05872464
Lead sponsor
Chulalongkorn University
Responsible party
Pornanong Aramwit, Pharm.D., Ph.D (Professor, Chulalongkorn University) — Principal investigator
First posted
May 24, 2023
Start date
Jul 1, 2024 (estimated)
Primary completion
May 30, 2025 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Jun 24, 2024

Study contacts

Pornanong Aramwit, Professor
Contact
aramwit@gmail.com
+66899217255
Pornanong Aramwit, Professor
principal investigator · Chulalongkorn University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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